The following data is part of a premarket notification filed by Magnetic Resonance Equipment Corp. with the FDA for Invasive Blood Pressure (ibp) Function, Model 9500 Multigas Monitor.
| Device ID | K983250 |
| 510k Number | K983250 |
| Device Name: | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR |
| Classification | Computer, Blood-pressure |
| Applicant | MAGNETIC RESONANCE EQUIPMENT CORP. 6 WASHINGTON AVE. Bay Shore, NY 11706 |
| Contact | G.ronald Morris |
| Correspondent | G.ronald Morris MAGNETIC RESONANCE EQUIPMENT CORP. 6 WASHINGTON AVE. Bay Shore, NY 11706 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-16 |
| Decision Date | 1999-12-12 |
| Summary: | summary |