The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Leo Iii Tx/rx Quadrature Knee Coil; Alpha Iii Tx/rx Quadrature Wrist Coil.
| Device ID | K023982 |
| 510k Number | K023982 |
| Device Name: | LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Contact | Christie Shumaker |
| Correspondent | Christie Shumaker USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-02 |
| Decision Date | 2003-02-21 |
| Summary: | summary |