Spacelabs, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
46
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K954962SPACELABS MEDICAL MULTIGAS ANALYZERMay 31, 1996
K951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMJuly 14, 1995
K950779HEART RATE VARIABILITY SOFTWARE OPTIONApril 25, 1995
K941165COMET CAPNOGRAPH MODULEOctober 6, 1994
K923788SPACE LABS MODEL 90560December 6, 1993
K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBEApril 20, 1992
K913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATIONOctober 4, 1991
K905065DEFIBRILLATOR LEAD ADAPTERApril 12, 1991
K910029PATIENT CARE MANAGEMENT SYSTEM MODIFICATIONJanuary 31, 1991
K896903FIRST MEDIC MODEL 510December 27, 1990
K904318LOCAL REPORT GENERATORDecember 18, 1990
K903702MODEL 90421 FLEXPORT INTERFACEOctober 19, 1990
K901209MODEL 90489 PULSE OXIMETER MODULEApril 30, 1990
K896942SPACELABS MODEL 90480 EEG MODULEMarch 8, 1990
K896427SPACELABS' MODEL 90514, MULTIGAS ANALYZERJanuary 24, 1990
K894093SPACELABS MODEL 90900November 30, 1989
K893867CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULESeptember 13, 1989
K864279SPACELABS MODEL 90419 PULSE OXIMETER MODULEMarch 11, 1987
K864506SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1November 25, 1986
K864505SPACELABS ARRHYTHMIA NET (TM) LEVEL 2November 24, 1986