Medical Device Manufacturer · US , Ann Arbor , MI

Mallinckrodt Sensor Systems, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1991

Recent clearances: GEM PREMIER PLUS MODEL 5500, GEM-PREMIER SYSTEM

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mallinckrodt Sensor Systems, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared Jun 28, 1996

GEM PREMIER PLUS MODEL 5500

Chemistry · 81d

Cleared Apr 03, 1991

GEM-PREMIER SYSTEM

Chemistry · 69d