BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
FDA 510(k) clearance K052646 · decided 2005-12-16
Clearance details
- K-number
- K052646
- Device name
- BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
- Applicant
- Biospace Corporation Limited
- Decision
- Substantially Equivalent
- Date received
- 2005-09-26
- Decision date
- 2005-12-16
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- MNW
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.