Company ยท US
Advanced Instrumentations, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2017. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGM | System, Monitoring, Perinatal | 4 |
| DPS | Electrocardiograph | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 2017 | K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging System Advanced Instrumentations, Inc. | IYO |
| Aug 31, 2017 | K172055 | DUS-7000 Digital Color Doppler Ultrasound System Advanced Instrumentations, Inc. | IYN |
| Nov 19, 2014 | K141194 | FM-3000 FETAL MONITOR Advanced Instrumentations, Inc. | HGM |
| Apr 23, 2014 | K132077 | PATIENT MONITOR Advanced Instrumentations, Inc. | MHX |
| Oct 25, 2013 | K132059 | DIAGNOSTIC ULTRASOUND SYSTEM Advanced Instrumentations, Inc. | IYN |
| Jan 11, 2013 | K123048 | PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO Advanced Instrumentations, Inc. | MHX |
| Jan 26, 2012 | K120075 | AM-6000 ANESTHESIA MACHINE Advanced Instrumentations, Inc. | BSZ |
| Dec 21, 2011 | K112317 | FM-9000 PLUS FETAL AND MATERNAL MONITOR Advanced Instrumentations, Inc. | HGM |
| Oct 27, 2011 | K112529 | TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER Advanced Instrumentations, Inc. | KNG |
| Sep 22, 2011 | K112022 | DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Advanced Instrumentations, Inc. | IYO |
| Sep 22, 2011 | K111934 | PD-100 SERIES ULTRASONIC POCKET DOPPLER Advanced Instrumentations, Inc. | KNG |
| Sep 21, 2011 | K112187 | FM-1000 PLUS FETAL MONITOR Advanced Instrumentations, Inc. | HGM |
| Sep 21, 2011 | K112159 | CMS-1000FM CENTRAL MONITORING SYSTEM Advanced Instrumentations, Inc. | HGM |
| Aug 24, 2011 | K111805 | ECG SERIES ELECTROCARDIOGRAPH Advanced Instrumentations, Inc. | DPS |
| Aug 5, 2011 | K112135 | ECG-6 SERIES ELECTROCARDIOGRAPH Advanced Instrumentations, Inc. | DPS |
| Jan 16, 2009 | K082887 | PM-1000F+PATIENT MONITOR Advanced Instrumentations, Inc. | MWI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||