BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500— 510(k) K062043
Substantially EquivalentOmron Healthcare, Inc.
FDA 510(k) clearance K062043 for BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500, Substantially Equivalent on 2006-11-07. Applicant: Omron Healthcare, Inc.. Device class: 2.
Clearance details
- Applicant
- Omron Healthcare, Inc.
- Product code
- Code MNW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
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