The following data is part of a premarket notification filed by Quality Electrodynamics, Llc. with the FDA for Pediatric 16, A1.5t Tim Coil/pediatric 16, A3t Tim Coil.
| Device ID | K140998 |
| 510k Number | K140998 |
| Device Name: | PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | QUALITY ELECTRODYNAMICS, LLC. 700 BETA DRIVE STE 100 Mayfield Village, OH 44143 |
| Contact | Kathleen Aras |
| Correspondent | Kathleen Aras QUALITY ELECTRODYNAMICS, LLC. 700 BETA DRIVE STE 100 Mayfield Village, 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 | 2014-04-18 |
| Decision Date | 2014-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020577 | K140998 | 000 |
| 00814848020416 | K140998 | 000 |