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FDA 510(k)

Carestation 750/750c

K-Number: K213867 · 2023-03-28

ApplicantDatex-Ohmeda, Inc.
Decision Date2023-03-28
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Carestation 750/750c 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 2023-03-28 under 510(k) 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. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K213867.

When did Carestation 750/750c receive FDA 510(k) clearance?

Carestation 750/750c received FDA 510(k) clearance on 2023-03-28, under 510(k) number K213867.

Who is the listed applicant for Carestation 750/750c?

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 Carestation 750/750c?

The FDA product code for Carestation 750/750c is BSZ.

Other records listing Datex-Ohmeda, Inc. as applicant

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Related Devices (Code: BSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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