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FDA 510(k)

CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)

K-Number: K000168 · 2000-04-13

ApplicantDatex-Ohmeda
Decision Date2000-04-13
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda. It received FDA 510(k) clearance on 2000-04-13 under 510(k) number K000168. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)?

CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) is a medical device that received FDA 510(k) clearance on 2000-04-13. The listed applicant is Datex-Ohmeda. The 510(k) number is K000168.

When did CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) receive FDA 510(k) clearance?

CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) received FDA 510(k) clearance on 2000-04-13, under 510(k) number K000168.

Who is the listed applicant for CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)?

The FDA 510(k) record lists Datex-Ohmeda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)?

The FDA product code for CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) is MHX.

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Related Devices (Code: MHX)

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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