FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
FDA 510(k) clearance K062484 · decided 2007-06-08
Clearance details
- K-number
- K062484
- Device name
- FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
- Applicant
- Flaem Nuova S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-25
- Decision date
- 2007-06-08
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- North Reading, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.