DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER

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 Datex-ohmeda D-tec Plus Anesthesia Vaporizer.

Pre-market Notification Details

Device IDK002878
510k NumberK002878
Device Name:DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
ClassificationVaporizer, Anesthesia, Non-heated
Applicant DATEX-OHMEDA, INC. OHMEDA DR. P.O. BOX 7550 Madison,  WI  53707 -7550
ContactDaniel Kosednar
CorrespondentDaniel Kosednar
DATEX-OHMEDA, INC. OHMEDA DR. P.O. BOX 7550 Madison,  WI  53707 -7550
Product CodeCAD  
CFR Regulation Number868.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-15
Decision Date2000-09-21

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