The following data is part of a premarket notification filed by Diametrics Medical, Ltd. with the FDA for Paratrend 7 Neotrend Multiparameter/sensor With Paratrend 7 Multiparameter Senior And Satellite Monitor System.
| Device ID | K972314 |
| 510k Number | K972314 |
| Device Name: | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM |
| Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
| Applicant | DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire, GB Hp11 2qh |
| Contact | Karima Hebri |
| Correspondent | Karima Hebri DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire, GB Hp11 2qh |
| Product Code | CCC |
| CFR Regulation Number | 868.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1997-12-19 |
| Summary: | summary |