510(k) K831246

WHISTLER IN-LINE PRESSURE RELEASE VALVE by Airlife, Inc. — Product Code CBP

K831246 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "WHISTLER IN-LINE PRESSURE RELEASE VALVE". The FDA issued a decision of Substantially Equivalent on July 26, 1983. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Airlife, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
April 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type