The following data is part of a premarket notification filed by Diametrics Medical, Ltd. with the FDA for Neurotrend Multiparameter Sensor, C7004s, To Operate With Paratrend 7+ Multiparameter Sensor, Mpm7001s, And Satellite Ms.
| Device ID | K980380 |
| 510k Number | K980380 |
| Device Name: | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire, GB Hp11 2qh |
| Contact | Jan Walters |
| Correspondent | Jan Walters DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire, GB Hp11 2qh |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-02 |
| Decision Date | 1999-07-14 |
| Summary: | summary |