PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM

Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

DIAMETRICS MEDICAL, LTD.

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.

Pre-market Notification Details

Device IDK972314
510k NumberK972314
Device Name:PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
ClassificationAnalyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Applicant DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire,  GB Hp11 2qh
ContactKarima Hebri
CorrespondentKarima Hebri
DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire,  GB Hp11 2qh
Product CodeCCC  
CFR Regulation Number868.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-20
Decision Date1997-12-19
Summary:summary

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