Medical Device Manufacturer · US , Walker , MI

S & W Medico Teknik - FDA 510(k) Cleared Devices

46 submissions · 46 cleared · Since 1984

Recent clearances: 9267 SPO2 ATHENA MODULE, TCPO2 9260 MODULE - SYSTEM ATHENA, MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

46

Total

46

Cleared

0

Denied

FDA 510(k) Regulatory Record - S & W Medico Teknik Cardiovascular ✕

28 devices

1-12 of 28

Cleared Apr 09, 1993

9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT

Cardiovascular · 87d

Cleared Feb 05, 1993

SYSTEM ATHENA, MODIFICATION

Cardiovascular · 668d

Cleared Oct 09, 1992

NIBP 9225 COMBI

Cardiovascular · 491d

Cleared Jun 23, 1992

Cardiovascular · 404d

Cleared Apr 10, 1992

PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE

Cardiovascular · 297d

Cleared Dec 05, 1991

SYSTEM ATHENA - PRODUCT ENHANCEMENTS

Cardiovascular · 240d

Cleared Dec 04, 1991

TYPE 9210 S/ECG

Cardiovascular · 464d

Cleared Sep 06, 1991

ACCUCORE TELEMETRY, MODIFICATION

Cardiovascular · 281d

Cleared Apr 26, 1991

ARRHYTHMIA 9215

Cardiovascular · 455d

Cleared Apr 20, 1990

Cardiovascular · 143d

Cleared Apr 20, 1990

Cardiovascular · 143d

Cleared Jan 26, 1990

TYPE 9541 RECORDER, PAPER CHART

Cardiovascular · 176d