MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
FDA 510(k) clearance K041327 · decided 2004-07-20
Clearance details
- K-number
- K041327
- Device name
- MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
- Applicant
- Med2000 S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-18
- Decision date
- 2004-07-20
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.