DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA

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 Tec 6 Plus Anesthesia Vaporizer, Datex-ohmeda Tec 6 Plus Nad Variant Anesthesia.

Pre-market Notification Details

Device IDK000275
510k NumberK000275
Device Name:DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
ClassificationVaporizer, Anesthesia, Non-heated
Applicant DATEX-OHMEDA, INC. P.O. BOX 7550 Madison,  WI  53707 -7550
ContactDaniel Kosednar
CorrespondentDaniel Kosednar
DATEX-OHMEDA, INC. P.O. BOX 7550 Madison,  WI  53707 -7550
Product CodeCAD  
CFR Regulation Number868.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-31
Decision Date2000-04-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682112536 K000275 000
00840682112789 K000275 000
00840682112659 K000275 000

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