510(k) K874418

LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470 by Life Support Products, Inc. — Product Code BTM

K874418 is an FDA 510(k) premarket notification submitted by Life Support Products, Inc. for the device "LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Life Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
October 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type