510(k) K880958

LIFEGUARD BACTERIAL AND VIRAL FILTER by Lifeguard Medical Products, Inc. — Product Code CAH

K880958 is an FDA 510(k) premarket notification submitted by Lifeguard Medical Products, Inc. for the device "LIFEGUARD BACTERIAL AND VIRAL FILTER". The FDA issued a decision of Substantially Equivalent on April 27, 1988. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Lifeguard Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1988
Date Received
March 7, 1988
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