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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 K822362
Device Name ALTA II ECG RECORDER
Applicant
Scole Engineering Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Scole Engineering Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2800
Classification Product Code
DSH  
Date Received08/06/1982
Decision Date 01/14/1983
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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