510(k) K112041
K112041 is an FDA 510(k) premarket notification submitted by Koo (Shanghai) Industries Co., Ltd. for the device "KOO SMALL VOLUME NEBULIZER (SVN)". The FDA issued a decision of Substantially Equivalent on December 22, 2011. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Koo (Shanghai) Industries Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2011
- Date Received
- July 18, 2011
- 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