510(k) K011608
K011608 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL". The FDA issued a decision of Substantially Equivalent on Aug 14, 2001. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Medical Advances, Inc. has 56 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 2001
- Date Received
- May 25, 2001
- 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)