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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K820417
Device Name #506 PORT. VITAL FUNCTIONS NEONATAL MON
Applicant
Ge Medical Systems Information Technologies
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ge Medical Systems Information Technologies
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/16/1982
Decision Date 03/04/1982
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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