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FDA 510(k)

ENGSTROM CARESTATION, ENGSTROM PRO

K-Number: K081842 · 2008-10-03

ApplicantDatex-Ohmeda, Inc.
Decision Date2008-10-03
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM CARESTATION, ENGSTROM PRO 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 2008-10-03 under 510(k) number K081842. 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 ENGSTROM CARESTATION, ENGSTROM PRO?

ENGSTROM CARESTATION, ENGSTROM PRO is a medical device that received FDA 510(k) clearance on 2008-10-03. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K081842.

When did ENGSTROM CARESTATION, ENGSTROM PRO receive FDA 510(k) clearance?

ENGSTROM CARESTATION, ENGSTROM PRO received FDA 510(k) clearance on 2008-10-03, under 510(k) number K081842.

Who is the listed applicant for ENGSTROM CARESTATION, ENGSTROM PRO?

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 ENGSTROM CARESTATION, ENGSTROM PRO?

The FDA product code for ENGSTROM CARESTATION, ENGSTROM PRO is CBK.

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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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