The following data is part of a premarket notification filed by Quality Electrodynamics, Llc. with the FDA for Breast Speeder Cx, Grid Holder Cx.
| Device ID | K142002 |
| 510k Number | K142002 |
| Device Name: | BREAST SPEEDER CX, GRID HOLDER CX |
| 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 | 2014-07-23 |
| Decision Date | 2014-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020614 | K142002 | 000 |
| 00814848020553 | K142002 | 000 |
| 00814848020195 | K142002 | 000 |