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FDA 510(k)

DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE

K-Number: K021376 · 2002-07-24

ApplicantDatex-Ohmeda
Decision Date2002-07-24
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda. It received FDA 510(k) clearance on 2002-07-24 under 510(k) number K021376. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE?

DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE is a medical device that received FDA 510(k) clearance on 2002-07-24. The listed applicant is Datex-Ohmeda. The 510(k) number is K021376.

When did DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE receive FDA 510(k) clearance?

DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE received FDA 510(k) clearance on 2002-07-24, under 510(k) number K021376.

Who is the listed applicant for DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE?

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 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE?

The FDA product code for DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE is DSI.

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Related Devices (Code: DSI)

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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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