The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Premier 9000 8 Channel Phased Array Ctl Spine Coil.
| Device ID | K031366 |
| 510k Number | K031366 |
| Device Name: | PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE 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 | 2003-04-30 |
| Decision Date | 2003-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682120869 | K031366 | 000 |
| 00840682119818 | K031366 | 000 |