510(k) K992193

ENDO-ESOPHAGEAL MR COIL by Surgi-Vision, Inc. — Product Code MOS

K992193 is an FDA 510(k) premarket notification submitted by Surgi-Vision, Inc. for the device "ENDO-ESOPHAGEAL MR COIL". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Surgi-Vision, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1999
Date Received
June 29, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type