510(k) K962161
K962161 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER NEBULIZER CAP MODEL 2D0868". The FDA issued a decision of Substantially Equivalent on Aug 15, 1996. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 15, 1996
- Date Received
- Jun 4, 1996
- 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
- 510(k)