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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K920765
Device Name EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200
Applicant
Electronic Monitoring Devices, Inc.
229 N. Lowell Ave.
Syracuse,  NY  13204
Applicant Contact STEPHEN ESPOSITO
Correspondent
Electronic Monitoring Devices, Inc.
229 N. Lowell Ave.
Syracuse,  NY  13204
Correspondent Contact STEPHEN ESPOSITO
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/19/1992
Decision Date 07/07/1992
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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