The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 472ge-128: Quadrature Lower Extremity Coil.
| Device ID | K023084 |
| 510k Number | K023084 |
| Device Name: | MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Anthony Dietzler |
| Correspondent | Anthony Dietzler MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-17 |
| Decision Date | 2002-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067127 | K023084 | 000 |
| 00884838066229 | K023084 | 000 |