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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 K840032
Device Name TELEPHONE RECEIVERS R101 R111
Applicant
Biometric Products, Inc.
4275a SW 73rd Ave.
Miami,  FL  33155
Applicant Contact KATCHIS, JR.
Correspondent
Biometric Products, Inc.
4275a SW 73rd Ave.
Miami,  FL  33155
Correspondent Contact KATCHIS, JR.
Regulation Number870.2920
Classification Product Code
DXH  
Date Received01/05/1984
Decision Date 10/26/1984
Decision SE - Postmarket Surveillance Required (SESP)
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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