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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K872443
Device Name COMPANION 50 REGULATOR/FLOWMETER
Applicant
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Applicant Contact HARTLEY C ERICSON
Correspondent
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Correspondent Contact HARTLEY C ERICSON
Regulation Number870.2300
Classification Product Code
DRT  
Date Received06/23/1987
Decision Date 07/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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