510(k) K060497
K060497 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "BABYAIR". The FDA issued a decision of Substantially Equivalent on July 11, 2006. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Promedic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2006
- Date Received
- February 24, 2006
- 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