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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 K092809
Device Name HRV ACQUIRE
Applicant
Wr Medical Electronics Co.
800 Lavanger Lane
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Wr Medical Electronics Co.
800 Lavanger Lane
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/11/2009
Decision Date 10/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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