Omron Healthcare, Inc. - FDA 510(k) Cleared Devices
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. Gastroenterology & Urology ✕
4 devices
Cleared
Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
Gastroenterology & Urology
111d
Cleared
Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
Gastroenterology & Urology
75d
Cleared
Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
Gastroenterology & Urology
162d
Cleared
Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
Gastroenterology & Urology
280d