Medical Device Manufacturer · US , Mchenry , IL

Physio-Control Corp. - FDA 510(k) Cleared Devices

80 submissions · 78 cleared · Since 1976

Recent clearances: LIFEPAK 12 BIPHASIC, NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM, LIFEPAK 500 BIPHASIC

80

Total

78

Cleared

0

Denied

FDA 510(k) Regulatory Record - Physio-Control Corp. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Nov 16, 1979

ADR-10600(ADR 400),10601 (ADR 300)

Gastroenterology & Urology · 122d

Cleared Jan 24, 1978

PERITONEAL DIALYSIS ADMIN. SET

Gastroenterology & Urology · 12d

Cleared Dec 20, 1977

PERITONEAL CYCLER & MANIFOLD SET

Gastroenterology & Urology · 36d

Cleared Nov 22, 1977

PRESSURE MONITOR MANOMETRIC SYS.

Gastroenterology & Urology · 132d

Cleared Nov 22, 1977

Gastroenterology & Urology · 70d