510(k) K133360
K133360 is an FDA 510(k) premarket notification submitted by Aerogen, Ltd. for the device "AERONEB SOLO; AERONEB SOLO ADAPTER". The FDA issued a decision of Substantially Equivalent on October 17, 2014. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Aerogen, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2014
- Date Received
- November 1, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type