The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Premier 7000 Ctl Spine Coil.
| Device ID | K980157 |
| 510k Number | K980157 |
| Device Name: | PREMIER 7000 CTL SPINE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 675-B ALPHA DR. Highland Heights, OH 44143 |
| Contact | Rony Thomas |
| Correspondent | Rony Thomas USA INSTRUMENTS, INC. 675-B ALPHA DR. Highland Heights, OH 44143 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682120852 | K980157 | 000 |
| 00840682120845 | K980157 | 000 |