The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Mark 9000 Phased Array Shoulder Coil.
| Device ID | K010946 |
| 510k Number | K010946 |
| Device Name: | MARK 9000 PHASED ARRAY SHOULDER COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Contact | Rony Thomas |
| Correspondent | Rony Thomas 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 | 2001-03-29 |
| Decision Date | 2001-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115810 | K010946 | 000 |
| 00840682114400 | K010946 | 000 |
| 00840682114387 | K010946 | 000 |