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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 K770038
Device Name MONITOR, HEARTWATCH HEART RATE
Applicant
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Correspondent
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Regulation Number870.2300
Classification Product Code
DRT  
Date Received01/10/1977
Decision Date 01/14/1977
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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