NORMATEC MVP
FDA 510(k) clearance K112890 · decided 2012-01-04
Clearance details
- K-number
- K112890
- Device name
- NORMATEC MVP
- Applicant
- NormaTec Industries, LP
- Decision
- Substantially Equivalent
- Date received
- 2011-09-30
- Decision date
- 2012-01-04
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.