DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500

Oximeter, Ear

DATEX-OHMEDA, INC.

The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Trusat Pulse Oximeter And Accessories, Model 3500.

Pre-market Notification Details

Device IDK040831
510k NumberK040831
Device Name:DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
ClassificationOximeter, Ear
Applicant DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville,  CO  80027
ContactScott Light
CorrespondentScott Light
DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville,  CO  80027
Product CodeDPZ  
CFR Regulation Number870.2710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-31
Decision Date2004-09-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682103374 K040831 000
00840682103183 K040831 000
00840682116749 K040831 000
00840682103145 K040831 000
00840682103121 K040831 000
00840682103114 K040831 000
00840682147316 K040831 000
00840682147309 K040831 000
00840682147293 K040831 000
00840682147286 K040831 000
00840682147279 K040831 000
00840682147262 K040831 000
00840682147255 K040831 000
00840682103206 K040831 000
00840682103213 K040831 000
00840682103305 K040831 000
00840682103268 K040831 000
00840682103718 K040831 000
00840682103398 K040831 000
00840682103350 K040831 000
00840682103312 K040831 000
00840682116695 K040831 000
00840682103282 K040831 000
00840682116725 K040831 000
00840682103251 K040831 000
00840682103244 K040831 000
00840682116770 K040831 000
00840682147248 K040831 000

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