510(k) K992193
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