510(k) K091272
K091272 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "BESMED JET NEBULIZER BOTTLE SET". The FDA issued a decision of Substantially Equivalent on November 10, 2009. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2009
- Date Received
- April 30, 2009
- 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