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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K031731
Device Name MR FIBER OPTIC ECG GATING SYSTEM
Applicant
Sa Instruments, Inc.
65 Main St.
Stony Brook,  NY  11790
Applicant Contact G. RONALD MORRIS
Correspondent
Sa Instruments, Inc.
65 Main St.
Stony Brook,  NY  11790
Correspondent Contact G. RONALD MORRIS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/04/2003
Decision Date 07/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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