Decision Date2023-03-28
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Carestation 750/750c is a medical device manufactured by Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2023-03-28 under approval number K213867. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Carestation 750/750c?
Carestation 750/750c is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Datex-Ohmeda, Inc.. The 510(k) number is K213867.
When was Carestation 750/750c approved by the FDA?
Carestation 750/750c received FDA 510(k) clearance on 2023-03-28, under approval number K213867.
What company makes Carestation 750/750c?
Carestation 750/750c is manufactured by Datex-Ohmeda, Inc..
What is the FDA product code for Carestation 750/750c?
The FDA product code for Carestation 750/750c is BSZ.
Other Devices by Datex-Ohmeda, Inc.
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K170872Aisys CS2
K172702Tec 820, Tec 850
K210384CARESCAPE R860
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Related Devices (Code: BSZ)
K151570Carestation 620/650/650CDatex-Ohmeda, Inc.
K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2Datex-Ohmeda, Inc.
K170872Aisys CS2Datex-Ohmeda, Inc.
K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB
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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.