AERONEB GO NEBULIZER, MODEL AG-AG2000
FDA 510(k) clearance K032849 · decided 2003-11-21
Clearance details
- K-number
- K032849
- Device name
- AERONEB GO NEBULIZER, MODEL AG-AG2000
- Applicant
- Aerogen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-12
- Decision date
- 2003-11-21
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mountain View, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Med recall (Z-0177-05) | Medical Industries America Inc | 2004-11-05 |