BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
FDA 510(k) clearance K062043 · decided 2006-11-07
Clearance details
- K-number
- K062043
- Device name
- BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
- Applicant
- Omron Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-19
- Decision date
- 2006-11-07
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- MNW
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.