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FDA 510(k)

COROMETRICS MODEL 556 NEONATAL MONITOR

K-Number: K900001 · 1990-11-29

ApplicantGe Medical Systems Information Technologies
Decision Date1990-11-29
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COROMETRICS MODEL 556 NEONATAL MONITOR 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 1990-11-29 under 510(k) number K900001. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COROMETRICS MODEL 556 NEONATAL MONITOR?

COROMETRICS MODEL 556 NEONATAL MONITOR is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K900001.

When did COROMETRICS MODEL 556 NEONATAL MONITOR receive FDA 510(k) clearance?

COROMETRICS MODEL 556 NEONATAL MONITOR received FDA 510(k) clearance on 1990-11-29, under 510(k) number K900001.

Who is the listed applicant for COROMETRICS MODEL 556 NEONATAL MONITOR?

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 MODEL 556 NEONATAL MONITOR?

The FDA product code for COROMETRICS MODEL 556 NEONATAL MONITOR is DQA.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: DQA)

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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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