FDA 510(k)

NGM ESTP MODULE

K-Number: K911646 · 1992-02-21

ApplicantDatex Division Instrumentarium Corp.

Decision Date1992-02-21

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NGM ESTP MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1992-02-21 under 510(k) number K911646. 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 NGM ESTP MODULE?

NGM ESTP MODULE is a medical device that received FDA 510(k) clearance on 1992-02-21. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K911646.

When did NGM ESTP MODULE receive FDA 510(k) clearance?

NGM ESTP MODULE received FDA 510(k) clearance on 1992-02-21, under 510(k) number K911646.

Who is the listed applicant for NGM ESTP MODULE?

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

What is the FDA product code for NGM ESTP MODULE?

The FDA product code for NGM ESTP MODULE is MHX.

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Other records listing Datex Division Instrumentarium Corp. as applicant

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Related Devices (Code: 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.