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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Amplifier And Signal Conditioner, Biopotential
510(k) Number K790203
Device Name INTERVAL TIMER MODEL V4295
Applicant
Electronics For Medicine, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Electronics For Medicine, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2050
Classification Product Code
DRR  
Date Received01/30/1979
Decision Date 03/02/1979
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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