SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
FDA 510(k) clearance K023817 · decided 2003-06-25
Clearance details
- K-number
- K023817
- Device name
- SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
- Applicant
- Clio Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-15
- Decision date
- 2003-06-25
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- MNW
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.