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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K772353
Device Name EKG ACQUISITION & ANALYSIS CART
Applicant
INTL. BUSINESS MACHINES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
INTL. BUSINESS MACHINES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Classification Product Code
LOS
Date Received12/23/1977
Decision Date 01/06/1978
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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