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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K871272
Device Name HUNTLEIGH FLOWPAC FP2000
Applicant
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Applicant Contact JAMES BRITTON
Correspondent
Huntleigh Technology, Inc.
227 Rte. 33 E.
Manalapan,  NJ  07726
Correspondent Contact JAMES BRITTON
Regulation Number870.5200
Classification Product Code
DRM  
Date Received03/31/1987
Decision Date 06/25/1987
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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