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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 K920099
Device Name GYMMAN
Applicant
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Applicant Contact STEPHEN L WHITTENBU
Correspondent
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Correspondent Contact STEPHEN L WHITTENBU
Regulation Number870.2300
Classification Product Code
DRT  
Date Received01/09/1992
Decision Date 03/09/1992
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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