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Prima, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
1
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K952012PRIMA CUSTOM ANESTESIA CIRCUITMay 22, 1995
K952021PRIMA HYUPERINFLATION SYSTEMMay 22, 1995
K952010PRIMA VENTILATOR HOSESMay 22, 1995
K952022PRIMA VOLUMN VENTILATORSSMay 22, 1995
K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSMay 22, 1995
K952017PRIMA MAPLESON D CIRCUITMay 22, 1995
K952013PRIMA GUEDEL AIRWAYSMay 22, 1995
K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSMay 22, 1995
K952018PRIMA COAXIAL CIRCUITSMay 22, 1995
K952015PRIMA FILTERMay 22, 1995
K952014PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSMay 22, 1995
K952011PRIMA BREATHING BAGSMay 22, 1995
K952019PRIMA ADULT GAS SAMPLING CIRCUITSMay 22, 1995
K952009PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITSMay 19, 1995
K944531PRIMA, INC. CORRUGATED TUBINGDecember 2, 1994
K944532PRIMA, INC. VENTILATOR HOSESDecember 2, 1994
K944535PRIMA, INC. GAS SAMPLING LINES AND CONNECTORSNovember 29, 1994
K944533PRIMA, INC. ADULT ANESTHESIA CIRCUITNovember 29, 1994
K944534PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONSNovember 29, 1994