The following data is part of a premarket notification filed by Diametrics Medical, Ltd. with the FDA for Paratrend 7 Multiparameter Senior And Satellite Monitor System With Paratrend 7 Plus Multiparameter Sensor.
| Device ID | K970906 |
| 510k Number | K970906 |
| Device Name: | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR |
| Classification | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| 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 | CBZ |
| Subsequent Product Code | CCC |
| Subsequent Product Code | CCE |
| CFR Regulation Number | 868.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1997-09-23 |
| Summary: | summary |