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 a medical device manufactured by Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2018-01-04 under approval 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. It is manufactured by Datex-Ohmeda, Inc.. The 510(k) number is K172702.
When was Tec 820, Tec 850 approved by the FDA?
Tec 820, Tec 850 received FDA 510(k) clearance on 2018-01-04, under approval number K172702.
What company makes Tec 820, Tec 850?
Tec 820, Tec 850 is manufactured by Datex-Ohmeda, Inc..
What is the FDA product code for Tec 820, Tec 850?
The FDA product code for Tec 820, Tec 850 is CAD.
Other Devices by Datex-Ohmeda, Inc.
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K170872Aisys CS2
K210384CARESCAPE R860
K213867Carestation 750/750c
K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
Related Devices (Code: CAD)
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.