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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K902381
Device Name PENLON BREATHING SYSTEM PRESSURE MONITOR
Applicant
PENLON, INC.
31, FRIENDS LN.
P.O. BOX 739
NEWTOWN,  PA  18940
Applicant Contact JIM GUNNERSON
Correspondent
PENLON, INC.
31, FRIENDS LN.
P.O. BOX 739
NEWTOWN,  PA  18940
Correspondent Contact JIM GUNNERSON
Regulation Number868.2600
Classification Product Code
CAP  
Date Received05/30/1990
Decision Date 08/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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