The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Array Open Breast Coil (model Obc-63 Pa).
| Device ID | K961525 |
| 510k Number | K961525 |
| Device Name: | ARRAY OPEN BREAST COIL (MODEL OBC-63 PA) |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha, WI 53186 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha, WI 53186 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-22 |
| Decision Date | 1996-09-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067042 | K961525 | 000 |
| 00884838065666 | K961525 | 000 |