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FDA 510(k)

DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES

K-Number: K062576 · 2006-09-29

ApplicantGE Healthcare
Decision Date2006-09-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2006-09-29 under 510(k) number K062576. 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 DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES?

DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is GE Healthcare. The 510(k) number is K062576.

When did DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES receive FDA 510(k) clearance?

DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES received FDA 510(k) clearance on 2006-09-29, under 510(k) number K062576.

Who is the listed applicant for DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES?

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

What is the FDA product code for DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES?

The FDA product code for DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES is MHX.

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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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