Company ยท US
Mortara Instrument, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2019. Name variants (Inc, Corp, punctuation) are merged.
51510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DPS | Electrocardiograph | 22 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 8 |
| LOS | 6 | |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 2 |
| DQA | Oximeter | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2019 | K182297 | Surveyor S2 Mortara Instrument, Inc. | DRG |
| Sep 4, 2018 | K173765 | Surveyor Patient Monitor Mortara Instrument, Inc. | MHX |
| Jan 11, 2017 | K161517 | Mortara Surveyor Patient Monitor Mortara Instrument, Inc. | MHX |
| Sep 3, 2016 | K161465 | CardioConfirm Mortara Instrument, Inc. | DQK |
| Aug 4, 2016 | K160685 | Surveyor S4 Mobile Monitor Mortara Instrument, Inc. | MHX |
| Feb 26, 2016 | K152626 | H3+ Holter Recorder Mortara Instrument, Inc. | MWJ |
| Jan 6, 2016 | K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems Mortara Instrument, Inc. | DPS |
| Dec 3, 2014 | K141020 | SURVEYOR S4 MOBILE MONITOR Mortara Instrument, Inc. | DRG |
| Nov 25, 2014 | K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM Mortara Instrument, Inc. | DXN |
| Nov 19, 2014 | K141811 | MORTARA MONITORING WAVEFORM VIEWER Mortara Instrument, Inc. | MHX |
| Sep 5, 2014 | K142105 | ELI 380 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Dec 3, 2013 | K131929 | SURVEYOR CENTRAL STATION Mortara Instrument, Inc. | MHX |
| Mar 22, 2013 | K123556 | MORTARA SURVEYOR PATIENT MONITOR Mortara Instrument, Inc. | MHX |
| Aug 2, 2012 | K122073 | ELI 280 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Jul 19, 2012 | K120865 | RSCRIBE ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Feb 18, 2011 | K102206 | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 Mortara Instrument, Inc. | DPS |
| Jul 2, 2010 | K101403 | ELI 250 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Jun 18, 2010 | K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 Mortara Instrument, Inc. | DPS |
| Apr 16, 2010 | K100127 | ELI 230 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Feb 19, 2010 | K093339 | ELI PC ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Dec 14, 2009 | K092663 | ELI 350 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Dec 29, 2008 | K082946 | MORTARA ELI 350 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Sep 24, 2008 | K081800 | T12S TELEMETRY TRANSMITTER Mortara Instrument, Inc. | DQA |
| Mar 15, 2007 | K070539 | MORTARA ELI 10 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Nov 15, 2006 | K062677 | ELI 350 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| May 15, 2006 | K060135 | MORTARA SURVEYOR TELEMETRY CENTRAL STATION Mortara Instrument, Inc. | MHX |
| Aug 24, 2005 | K050896 | H12+ HOLTER RECORDER Mortara Instrument, Inc. | DSH |
| Feb 25, 2005 | K043010 | HOLTER RECORDER H3+ Mortara Instrument, Inc. | MWJ |
| Jul 25, 2003 | K031182 | ELI 200+ AUDICOR Mortara Instrument, Inc. | DPS |
| Sep 6, 2002 | K022618 | X-SCRIBE II Mortara Instrument, Inc. | DPS |
| Jun 27, 2002 | K021373 | H12+HOLTER RECORDER Mortara Instrument, Inc. | MWJ |
| Jun 11, 2001 | K004017 | H-SCRIBE Mortara Instrument, Inc. | MLO |
| Jan 8, 1998 | K974149 | AMBULATORY X-12 TELEMETRY MODULE Mortara Instrument, Inc. | DRG |
| Aug 12, 1997 | K942685 | ECG REVIEW STATION Mortara Instrument, Inc. | DXJ |
| Apr 15, 1994 | K933143 | MODEL ELI 300 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | LOS |
| Apr 27, 1993 | K930558 | MORTARA INSTRUMENT, INC. E-SCRIBE Mortara Instrument, Inc. | DPS |
| Nov 10, 1992 | K922927 | MORTARA INSTRUMENT ST CENTRAL STATION Mortara Instrument, Inc. | DPS |
| Nov 10, 1992 | K915730 | MORTARA INSTRUMENT ODEL ELI 50I Mortara Instrument, Inc. | LOS |
| Sep 4, 1992 | K920627 | MODEL ELI 100 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | LOS |
| Sep 4, 1992 | K920626 | MODEL ELI 200 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | LOS |
| Apr 28, 1992 | K920377 | MORTARA INSTRUMENT MODEL ECG PREVU Mortara Instrument, Inc. | LOS |
| Aug 7, 1991 | K911097 | PR4 Mortara Instrument, Inc. | DSH |
| Nov 5, 1990 | K900720 | MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED) Mortara Instrument, Inc. | DSI |
| Aug 23, 1990 | K902652 | MORTARA INSTRUMENT MODEL ELI 50 Mortara Instrument, Inc. | DRT |
| Dec 13, 1989 | K895232 | MODEL ELI-100/ST ELECTROCARDIOGRAPH Mortara Instrument, Inc. | LOS |
| Mar 9, 1988 | K880664 | MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED) Mortara Instrument, Inc. | DSI |
| Feb 20, 1987 | K864580 | MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM) Mortara Instrument, Inc. | DPS |
| Aug 28, 1986 | K861851 | SIEMENS-ELEMA (SICARD-P) Mortara Instrument, Inc. | DPS |
| Aug 28, 1986 | K861850 | BURDICK DIVISION (E-500) Mortara Instrument, Inc. | DPS |
| Jul 29, 1985 | K851702 | MORTARA INSTRUMENT MODEL EL-1 Mortara Instrument, Inc. | DSI |
Newest 50 of 51.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2015 | Mortara Instrument, Inc ELI 380 Electrocardiograph.
The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380
simultaneously acquires data from ea Terminated |
DPS | K142105 |
| Oct 22, 2014 | Mortara Instrument, Inc Mortara Surveyor S12 and Surveyor S19 Patient Monitors.
Product Usage:
They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood press Terminated |
MHX | K123556 |