ANAESTHESIA RECORD KEEPER

Gas-machine, Anesthesia

DATEX DIVISION INSTRUMENTARIUM CORP.

The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Anaesthesia Record Keeper.

Pre-market Notification Details

Device IDK923172
510k NumberK923172
Device Name:ANAESTHESIA RECORD KEEPER
ClassificationGas-machine, Anesthesia
Applicant DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland,  FI
ContactHannu Ahjopalo
CorrespondentHannu Ahjopalo
DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland,  FI
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-29
Decision Date1994-08-09

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