510(k) K001312
K001312 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL". The FDA issued a decision of Substantially Equivalent on Jun 20, 2000. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Igc-Medical Advances, Inc. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 20, 2000
- Date Received
- Apr 26, 2000
- 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
- 510(k)