The following data is part of a premarket notification filed by Quality Electrodynamics with the FDA for Speeder 1.5t Wrist Array Coil.
| Device ID | K072935 |
| 510k Number | K072935 |
| Device Name: | SPEEDER 1.5T WRIST ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | QUALITY ELECTRODYNAMICS 777 BETA DR. Mayfield Village, OH 44143 |
| Contact | Christie Zydyk |
| 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 | 2007-10-17 |
| Decision Date | 2007-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020454 | K072935 | 000 |
| 00814848020027 | K072935 | 000 |