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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K790999
Device Name APOLLO HEART RATE INDICATOR
Applicant
Apollo Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Apollo Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2780
Classification Product Code
JOM  
Date Received05/29/1979
Decision Date 06/22/1979
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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