510(k) K880637

BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES by Baxter Healthcare Corp — Product Code BZO

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

Source: FDA 510(k) database entry for K880637. Report a data issue: hello@regdatalab.com.