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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K924282
Device Name MODEL 320 MR-COMPATIBLE PULSE OXIMETER
Applicant
Magnetic Resonance Equipment Corp.
P.O. Box 5489
Bay Shore,  NY  11706
Applicant Contact RONALD MORRIS
Correspondent
Magnetic Resonance Equipment Corp.
P.O. Box 5489
Bay Shore,  NY  11706
Correspondent Contact RONALD MORRIS
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/25/1992
Decision Date 05/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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