The following data is part of a premarket notification filed by Quality Electrodynamics with the FDA for Txrx 15ch Knee Coil (1.5t And 3t), Txrx Cp Extremity Coil 3t.
| Device ID | K082636 |
| 510k Number | K082636 |
| Device Name: | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | QUALITY ELECTRODYNAMICS 777 BETA DR. Mayfield Village, OH 44143 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-10 |
| Decision Date | 2008-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020355 | K082636 | 000 |
| 00814848020331 | K082636 | 000 |
| 00814848020317 | K082636 | 000 |
| 00814848020294 | K082636 | 000 |
| 00814848020270 | K082636 | 000 |
| 00814848020096 | K082636 | 000 |
| 00814848020065 | K082636 | 000 |
| 00814848020041 | K082636 | 000 |