The following data is part of a premarket notification filed by Magnetic Resonance Equipment Corp. with the FDA for Model 9500 Mr-compatible Multigas Monitor.
| Device ID | K954120 |
| 510k Number | K954120 |
| Device Name: | MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MAGNETIC RESONANCE EQUIPMENT CORP. 5 GRANT AVE. Bay Shore, NY 11706 |
| Contact | G. Ronald Morris |
| Correspondent | G. Ronald Morris MAGNETIC RESONANCE EQUIPMENT CORP. 5 GRANT AVE. Bay Shore, NY 11706 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-01 |
| Decision Date | 1997-04-02 |