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 |