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S & W Medico Teknik

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
49
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K964593DIASCOPE TRAVELLER PLUS (4053)June 30, 1997
K9409339267 SPO2 ATHENA MODULENovember 29, 1995
K9421963050 DIASCOPE NT PATIENT MONITORJune 28, 1995
K913013TCPO2 9260 MODULE - SYSTEM ATHENAMay 3, 1994
K9348879750 ATHENA ETHERNET OPTIONJanuary 14, 1994
K915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAJune 29, 1993
K9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTApril 9, 1993
K9234189293/1 INTERFACE MODULEFebruary 23, 1993
K911611SYSTEM ATHENA, MODIFICATIONFebruary 5, 1993
K922314VENTILATOR INTERFACE 9291/4December 17, 1992
K912815NIBP 9225 COMBIOctober 9, 1992
K912000TYPE INTERFACE 9271/1 INCUBATOR/WARMERSeptember 21, 1992
K912183TYPE 9050/NEOJune 23, 1992
K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAMay 5, 1992
K912816PRESS 1 PRESS 2 9220 UPDATING OF THE MODULEApril 10, 1992
K912049SYSTEM ATHENA - PRODUCT ENHANCEMENTSDecember 5, 1991
K903940TYPE 9210 S/ECGDecember 4, 1991
K911761SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATIONOctober 31, 1991
K905506ACCUCORE TELEMETRY, MODIFICATIONSeptember 6, 1991
K911264CALIBRATION KITAugust 2, 1991