510(k) K040640
K040640 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL". The FDA issued a decision of Substantially Equivalent on Mar 22, 2004. 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
- Mar 22, 2004
- Date Received
- Mar 10, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)