510(k) K032849
K032849 is an FDA 510(k) premarket notification submitted by Aerogen, Inc. for the device "AERONEB GO NEBULIZER, MODEL AG-AG2000". The FDA issued a decision of Substantially Equivalent on November 21, 2003. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Aerogen, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2003
- Date Received
- September 12, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type