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FDA 510(k)

COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD

K-Number: K911310 · 1991-06-10

ApplicantGe Medical Systems Information Technologies
Decision Date1991-06-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K911310. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD?

COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K911310.

When did COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD receive FDA 510(k) clearance?

COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911310.

Who is the listed applicant for COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD?

The FDA product code for COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD is DXN.

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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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