CO2/02 MONITOR MULTINEX

Analyzer, Gas, Nitrogen, Gaseous-phase

DATASCOPE CORP.

The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Co2/02 Monitor Multinex.

Pre-market Notification Details

Device IDK872024
510k NumberK872024
Device Name:CO2/02 MONITOR MULTINEX
ClassificationAnalyzer, Gas, Nitrogen, Gaseous-phase
Applicant DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus,  NJ  07653
ContactArthur Friedman
CorrespondentArthur Friedman
DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 Paramus,  NJ  07653
Product CodeCCI  
CFR Regulation Number868.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-26
Decision Date1988-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.