510(k) K780340

IMV SYSTEM by Lkb Instruments, Inc. — Product Code CBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1978
Date Received
March 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Breathing System (Calibrated)
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type