510(k) K232507
K232507 is an FDA 510(k) premarket notification submitted by Aerogen, Ltd. for the device "Aerogen®Solo Nebulizer System". The FDA issued a decision of Substantially Equivalent on May 10, 2024. 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
- May 10, 2024
- Date Received
- August 18, 2023
- 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