Medical Device Manufacturer · US , Walker , MI

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

46 submissions · 46 cleared · Since 1984
46
Total
46
Cleared
0
Denied
46 devices
26-46 of 46
Cleared Feb 28, 1990
TYPE 9292 INTERFACE CAPNOGRAPH
K896737 · CCK
Anesthesiology · 90d
Cleared Feb 22, 1990
TYPE EXPIRED CO2 9270, CAPNOGRAPH
K895001 · CCK
Anesthesiology · 203d
Cleared Jan 26, 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · DSF
Cardiovascular · 176d
Cleared Oct 03, 1989
SELECTRODE
K894920 · DRX
Cardiovascular · 62d
Cleared Oct 02, 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · DRT
Cardiovascular · 70d
Cleared Oct 02, 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · DRT
Cardiovascular · 70d
Cleared May 11, 1989
TYPE 9225 NIBP
K890005 · DXN
Cardiovascular · 128d
Cleared May 01, 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · DRX
Cardiovascular · 153d
Cleared Apr 26, 1989
TYPE 9040 SYSTEM ATHENA
K884116 · DPS
Cardiovascular · 208d
Cleared Apr 26, 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · DRT
Cardiovascular · 208d
Cleared Apr 25, 1989
TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA
K884118 · DSK
Cardiovascular · 207d
Cleared Apr 25, 1989
TYPE 9266 SAO2 SYSTEM ATHENA
K884121 · DQA
Anesthesiology · 207d
Cleared Apr 25, 1989
TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
K884122 · DXG
Cardiovascular · 207d
Cleared Mar 10, 1989
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
K884981 · DRX
Cardiovascular · 101d
Cleared Mar 10, 1989
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982 · DRX
Cardiovascular · 101d
Cleared Mar 09, 1989
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
K884983 · DRX
Cardiovascular · 100d
Cleared Mar 09, 1989
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
K884984 · DRX
Cardiovascular · 100d
Cleared Nov 02, 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119 · FLL
General Hospital · 33d
Cleared Mar 13, 1987
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586 · DRX
Cardiovascular · 112d
Cleared Aug 05, 1985
DEFI 2
K851931 · LDD
Cardiovascular · 95d
Cleared Oct 26, 1984
DIASCOPE 2
K833689 · DRT
Cardiovascular · 374d
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