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FDA 510(k)

TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES

K-Number: K021955 · 2002-10-08

ApplicantDatex-Ohmeda, Inc.
Decision Date2002-10-08
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K021955. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES?

TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K021955.

When did TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES receive FDA 510(k) clearance?

TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES received FDA 510(k) clearance on 2002-10-08, under 510(k) number K021955.

Who is the listed applicant for TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES?

The FDA 510(k) record lists Datex-Ohmeda, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES?

The FDA product code for TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES is DQA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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