510(k) K790896

TWO-WAY ANESTHESIA FILTER by Pharmaseal Div., Baxter Healthcare Corp. — Product Code CAH

K790896 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "TWO-WAY ANESTHESIA FILTER". The FDA issued a decision of Substantially Equivalent on June 5, 1979. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1979
Date Received
May 8, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type