510(k) K895014
K895014 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER BAFFLED TEE ADAPTER". The FDA issued a decision of Substantially Equivalent on Oct 30, 1989. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 30, 1989
- Date Received
- Aug 8, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Connector, Airway (Extension)
- Device Class
- Class I
- Regulation Number
- 868.5810
- Review Panel
- AN
- Submission Type
- 510(k) Exempt