AESPIRE 7900, AESPIRE VIEW

Gas-machine, Anesthesia

DATEX-OHMEDA

The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Aespire 7900, Aespire View.

Pre-market Notification Details

Device IDK122445
510k NumberK122445
Device Name:AESPIRE 7900, AESPIRE VIEW
ClassificationGas-machine, Anesthesia
Applicant DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR Madison,  WI  53707
ContactJames Raskob
CorrespondentJames Raskob
DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR Madison,  WI  53707
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-10
Decision Date2012-10-12
Summary:summary

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