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FDA 510(k)

Carestation 620/650/650C

K-Number: K151570 · 2016-01-21

ApplicantDatex-Ohmeda, Inc.
Decision Date2016-01-21
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Carestation 620/650/650C is a medical device manufactured by Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2016-01-21 under approval number K151570. 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 620/650/650C?

Carestation 620/650/650C is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Datex-Ohmeda, Inc.. The 510(k) number is K151570.

When was Carestation 620/650/650C approved by the FDA?

Carestation 620/650/650C received FDA 510(k) clearance on 2016-01-21, under approval number K151570.

What company makes Carestation 620/650/650C?

Carestation 620/650/650C is manufactured by Datex-Ohmeda, Inc..

What is the FDA product code for Carestation 620/650/650C?

The FDA product code for Carestation 620/650/650C is BSZ.

Other Devices by Datex-Ohmeda, Inc.

K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 K170872Aisys CS2 K172702Tec 820, Tec 850 K210384CARESCAPE R860 K213867Carestation 750/750c K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

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Related Devices (Code: BSZ)

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 K171311A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB

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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