510(k) K001742

RESUSCI INFLATE-A-SHIELD CPR BARRIER by Laerdal Medical Corp. — Product Code CBP

K001742 is an FDA 510(k) premarket notification submitted by Laerdal Medical Corp. for the device "RESUSCI INFLATE-A-SHIELD CPR BARRIER". The FDA issued a decision of Substantially Equivalent on October 6, 2000. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Laerdal Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2000
Date Received
June 8, 2000
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