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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K992193
Device Name ENDO-ESOPHAGEAL MR COIL
Applicant
SURGI-VISION, INC.
9250 RUMSEY RD., SUITE 100
COLUMBIA,  MD  21045
Applicant Contact NANCY TAYLOR
Correspondent
SURGI-VISION, INC.
9250 RUMSEY RD., SUITE 100
COLUMBIA,  MD  21045
Correspondent Contact NANCY TAYLOR
Regulation Number892.1000
Classification Product Code
MOS  
Date Received06/29/1999
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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