Medical Device Manufacturer · US , Vernon Hills , IL

Omron Healthcare, Inc. - FDA 510(k) Cleared Devices

68 submissions · 67 cleared · Since 1991

Recent clearances: Omron Model BP7900 Blood Pressure Monitor + EKG, Focus TENS Therapy, Model PM710-M/-L, HEM-6410T-ZL Wrist Blood Pressure Monitor

68

Total

67

Cleared

1

Denied

FDA 510(k) Regulatory Record - Omron Healthcare, Inc. Anesthesiology ✕

7 devices

1-7 of 7

Cleared Sep 30, 2014

Anesthesiology · 151d

Cleared Sep 02, 2011

Anesthesiology · 157d

Cleared Feb 23, 2007

OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22

Anesthesiology · 203d

Cleared May 25, 2006

OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30

Anesthesiology · 62d

Cleared Sep 15, 1992

Anesthesiology · 90d

Cleared Sep 15, 1992

Anesthesiology · 84d

Cleared May 06, 1992

OMRON COMPRESSOR NEBULIZER- MODEL NE-C09

Anesthesiology · 194d