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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 K854847
Device Name PHYSIO-DYNE ECG/HR 3
Applicant
Physio-Dyne Industrument Corp.
35 Jeanette Dr.
P.O. Box 209
Massapequa,  NY  11758
Applicant Contact DONALD B FALK
Correspondent
Physio-Dyne Industrument Corp.
35 Jeanette Dr.
P.O. Box 209
Massapequa,  NY  11758
Correspondent Contact DONALD B FALK
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/04/1985
Decision Date 06/16/1986
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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