The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Hrh-63-8 Head Array Coil.
| Device ID | K013159 |
| 510k Number | K013159 |
| Device Name: | HRH-63-8 HEAD ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | Tom Schubert |
| Correspondent | Tom Schubert MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-21 |
| Decision Date | 2001-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838087323 | K013159 | 000 |
| 00884838080911 | K013159 | 000 |
| 00884838066281 | K013159 | 000 |
| 00884838065659 | K013159 | 000 |
| 00884838065642 | K013159 | 000 |
| 00884838065635 | K013159 | 000 |