The following data is part of a premarket notification filed by Quality Electrodynamics, Llc with the FDA for 16ch Tx/rx Knee Speeder.
| Device ID | K161193 |
| 510k Number | K161193 |
| Device Name: | 16ch Tx/Rx Knee SPEEDER |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Quality Electrodynamics, LLC 700 Beta Drive Suite 100 Mayfield Village, OH 44143 |
| Contact | Kathleen Aras |
| Correspondent | Kathleen Aras Quality Electrodynamics, LLC 700 Beta Drive Suite 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 | 2016-04-27 |
| Decision Date | 2016-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020645 | K161193 | 000 |