Tec 820, Tec 850

Vaporizer, Anesthesia, Non-heated

Datex-Ohmeda, Inc.

The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Tec 820, Tec 850.

Pre-market Notification Details

Device IDK172702
510k NumberK172702
Device Name:Tec 820, Tec 850
ClassificationVaporizer, Anesthesia, Non-heated
Applicant Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison,  WI  53707 -7550
ContactTrishia Mercier
CorrespondentTrishia Mercier
Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison,  WI  53707 -7550
Product CodeCAD  
CFR Regulation Number868.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-07
Decision Date2018-01-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682124751 K172702 000
00840682124744 K172702 000
00840682124737 K172702 000
00840682124720 K172702 000

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