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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K851971
Device Name SERIES 7000/HOLTER RECORDER
Applicant
Pfizer, Inc.
P.O. Box 23181
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact THOMAS MASSOPUST
Correspondent
Pfizer, Inc.
P.O. Box 23181
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact THOMAS MASSOPUST
Regulation Number870.2800
Classification Product Code
DSH  
Date Received05/07/1985
Decision Date 06/20/1985
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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