The following data is part of a premarket notification filed by Magnetic Resonance Equipment Corp. with the FDA for Model 320 Mr-compatible Pulse Oximeter.
| Device ID | K924282 |
| 510k Number | K924282 |
| Device Name: | MODEL 320 MR-COMPATIBLE PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | MAGNETIC RESONANCE EQUIPMENT CORP. PO. BOX 5489 Bay Shore, NY 11706 |
| Contact | Ronald Morris |
| Correspondent | Ronald Morris MAGNETIC RESONANCE EQUIPMENT CORP. PO. BOX 5489 Bay Shore, NY 11706 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-25 |
| Decision Date | 1993-05-07 |