Company ยท DK
S & W Medico Teknik
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1995. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 8 |
| DRX | Electrode, Electrocardiograph | 7 |
| DQA | Oximeter | 6 |
| CBK | Ventilator, Continuous, Facility Use | 3 |
| DPS | Electrocardiograph | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| DSK | Computer, Blood-Pressure | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| FLL | Continuous Measurement Thermometer | 2 |
| BXK | Gas, Calibration (Specified Concentration) | 1 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 1 |
| DSF | Recorder, Paper Chart | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| FMZ | Incubator, Neonatal | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 1995 | K940933 | 9267 SPO2 ATHENA MODULE S & W Medico Teknik, DK | DQA |
| May 3, 1994 | K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA S & W Medico Teknik, DK | LKD |
| Jun 29, 1993 | K915633 | MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA S & W Medico Teknik, DK | FLL |
| Apr 9, 1993 | K930134 | 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT S & W Medico Teknik, DK | DPS |
| Feb 23, 1993 | K923418 | 9293/1 INTERFACE MODULE S & W Medico Teknik, DK | DQA |
| Feb 5, 1993 | K911611 | SYSTEM ATHENA, MODIFICATION S & W Medico Teknik, DK | DRT |
| Dec 17, 1992 | K922314 | VENTILATOR INTERFACE 9291/4 S & W Medico Teknik, DK | CBK |
| Oct 9, 1992 | K912815 | NIBP 9225 COMBI S & W Medico Teknik, DK | DXN |
| Sep 21, 1992 | K912000 | TYPE INTERFACE 9271/1 INCUBATOR/WARMER S & W Medico Teknik, DK | FMZ |
| Jun 23, 1992 | K912183 | TYPE 9050/NEO S & W Medico Teknik, DK | DPS |
| May 5, 1992 | K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA S & W Medico Teknik, DK | CCE |
| Apr 10, 1992 | K912816 | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE S & W Medico Teknik, DK | DSK |
| Dec 5, 1991 | K912049 | SYSTEM ATHENA - PRODUCT ENHANCEMENTS S & W Medico Teknik, DK | DRT |
| Dec 4, 1991 | K903940 | TYPE 9210 S/ECG S & W Medico Teknik, DK | DSI |
| Oct 31, 1991 | K911761 | SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION S & W Medico Teknik, DK | DQA |
| Sep 6, 1991 | K905506 | ACCUCORE TELEMETRY, MODIFICATION S & W Medico Teknik, DK | DSI |
| Aug 2, 1991 | K911264 | CALIBRATION KIT S & W Medico Teknik, DK | BXK |
| Apr 26, 1991 | K900366 | ARRHYTHMIA 9215 S & W Medico Teknik, DK | DSI |
| Sep 27, 1990 | K902779 | MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA S & W Medico Teknik, DK | DQA |
| Aug 14, 1990 | K896738 | TYPE 9293 INTERFACE PULSEOX S & W Medico Teknik, DK | DQA |
| Jul 17, 1990 | K884120 | TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) S & W Medico Teknik, DK | BZQ |
| Apr 20, 1990 | K896700 | TYPE 9140/NEO S & W Medico Teknik, DK | DRT |
| Apr 20, 1990 | K896699 | TYPE 9040/NEO S & W Medico Teknik, DK | DRT |
| Feb 28, 1990 | K896737 | TYPE 9292 INTERFACE CAPNOGRAPH S & W Medico Teknik, DK | CCK |
| Feb 28, 1990 | K896736 | TYPE 9291 INTERFACE RESPIRATOR S & W Medico Teknik, DK | CBK |
| Feb 28, 1990 | K896735 | TYPE 9290 INTERFACE RESPIRATOR S & W Medico Teknik, DK | CBK |
| Feb 22, 1990 | K895001 | TYPE EXPIRED CO2 9270, CAPNOGRAPH S & W Medico Teknik, DK | CCK |
| Jan 26, 1990 | K895111 | TYPE 9541 RECORDER, PAPER CHART S & W Medico Teknik, DK | DSF |
| Oct 3, 1989 | K894920 | SELECTRODE S & W Medico Teknik, DK | DRX |
| Oct 2, 1989 | K894700 | TYPE PDU/CDU 9040 (SYSTEM ATHENA) S & W Medico Teknik, DK | DRT |
| Oct 2, 1989 | K894699 | TYPE 9140 (SYSTEM ATHENA) S & W Medico Teknik, DK | DRT |
| May 11, 1989 | K890005 | TYPE 9225 NIBP S & W Medico Teknik, DK | DXN |
| May 1, 1989 | K884980 | F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM S & W Medico Teknik, DK | DRX |
| Apr 26, 1989 | K884117 | TYPE 9210 ECG SYSTEM ATHENA S & W Medico Teknik, DK | DRT |
| Apr 26, 1989 | K884116 | TYPE 9040 SYSTEM ATHENA S & W Medico Teknik, DK | DPS |
| Apr 25, 1989 | K884122 | TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA S & W Medico Teknik, DK | DXG |
| Apr 25, 1989 | K884121 | TYPE 9266 SAO2 SYSTEM ATHENA S & W Medico Teknik, DK | DQA |
| Apr 25, 1989 | K884118 | TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA S & W Medico Teknik, DK | DSK |
| Mar 10, 1989 | K884982 | M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68 S & W Medico Teknik, DK | DRX |
| Mar 10, 1989 | K884981 | F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM S & W Medico Teknik, DK | DRX |
| Mar 9, 1989 | K884984 | M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 S & W Medico Teknik, DK | DRX |
| Mar 9, 1989 | K884983 | M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 S & W Medico Teknik, DK | DRX |
| Nov 2, 1988 | K884119 | TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA S & W Medico Teknik | FLL |
| Mar 13, 1987 | K864586 | S&W ELECTRODE TYPES 888, 844, 988 AND 944 S & W Medico Teknik | DRX |
| Aug 5, 1985 | K851931 | DEFI 2 S & W Medico Teknik | LDD |
| Oct 26, 1984 | K833689 | DIASCOPE 2 S & W Medico Teknik | DRT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||