510(k) K880637
K880637 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES". The FDA issued a decision of Substantially Equivalent on Apr 11, 1988. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 11, 1988
- Date Received
- Feb 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Tubing And Support, Ventilator (W Harness)
- Device Class
- Class I
- Regulation Number
- 868.5975
- Review Panel
- AN
- Submission Type
- 510(k) Exempt