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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 K923664
Device Name SCOLE 300 ECG RECORDER
Applicant
Scole Engineering Co.
12065 Jefferson Blvd.
Culver City,  CA  90230
Applicant Contact LYNDA COLE
Correspondent
Scole Engineering Co.
12065 Jefferson Blvd.
Culver City,  CA  90230
Correspondent Contact LYNDA COLE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received07/22/1992
Decision Date 01/13/1994
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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