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FDA 510(k)

Tec 820, Tec 850

K-Number: K172702 · 2018-01-04

ApplicantDatex-Ohmeda, Inc.
Decision Date2018-01-04
Product CodeCAD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Tec 820, Tec 850 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 2018-01-04 under 510(k) number K172702. The device is classified under product code CAD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tec 820, Tec 850?

Tec 820, Tec 850 is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K172702.

When did Tec 820, Tec 850 receive FDA 510(k) clearance?

Tec 820, Tec 850 received FDA 510(k) clearance on 2018-01-04, under 510(k) number K172702.

Who is the listed applicant for Tec 820, Tec 850?

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 Tec 820, Tec 850?

The FDA product code for Tec 820, Tec 850 is CAD.

Other records listing Datex-Ohmeda, Inc. as applicant

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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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