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FDA 510(k)

GE DATEX-OHMEDA ENGSTROM CARESTATION

K-Number: K062710 · 2006-12-08

ApplicantDatex-Ohmeda, Inc.
Decision Date2006-12-08
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GE DATEX-OHMEDA ENGSTROM CARESTATION 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 2006-12-08 under 510(k) number K062710. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE DATEX-OHMEDA ENGSTROM CARESTATION?

GE DATEX-OHMEDA ENGSTROM CARESTATION is a medical device that received FDA 510(k) clearance on 2006-12-08. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K062710.

When did GE DATEX-OHMEDA ENGSTROM CARESTATION receive FDA 510(k) clearance?

GE DATEX-OHMEDA ENGSTROM CARESTATION received FDA 510(k) clearance on 2006-12-08, under 510(k) number K062710.

Who is the listed applicant for GE DATEX-OHMEDA ENGSTROM CARESTATION?

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 GE DATEX-OHMEDA ENGSTROM CARESTATION?

The FDA product code for GE DATEX-OHMEDA ENGSTROM CARESTATION is CBK.

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Related Devices (Code: CBK)

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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