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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K903331
Device Name ROZINN 151
Applicant
Rozinn Electronics, Inc.
71-22 Myrtle Ave.
Glendale,  NY  11385
Applicant Contact MARK ROSOFF
Correspondent
Rozinn Electronics, Inc.
71-22 Myrtle Ave.
Glendale,  NY  11385
Correspondent Contact MARK ROSOFF
Regulation Number870.2800
Classification Product Code
DSH  
Date Received07/25/1990
Decision Date 10/22/1990
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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