NEVONI CLASSIC, MODEL 6600-PO
FDA 510(k) clearance K082878 · decided 2008-12-30
Clearance details
- K-number
- K082878
- Device name
- NEVONI CLASSIC, MODEL 6600-PO
- Applicant
- Nsr Comercio E Representacoes Ltda
- Decision
- Substantially Equivalent
- Date received
- 2008-09-29
- Decision date
- 2008-12-30
- Days to decision
- 92 days
- Clearance type
- Abbreviated
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Foxboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.