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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 K952790
Device Name LOG-A-RYTHM MODEL 100 AND MODEL 1001
Applicant
Nian-Crae, Inc.
13 Cortland Dr.
Somerset,  NJ  08873
Applicant Contact NICKI ANN NEWBY
Correspondent
Nian-Crae, Inc.
13 Cortland Dr.
Somerset,  NJ  08873
Correspondent Contact NICKI ANN NEWBY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received06/19/1995
Decision Date 10/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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