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FDA 510(k)

COROMETRICS MODEL 510 AND 511 MONITOR

K-Number: K962781 · 1997-03-06

ApplicantGe Medical Systems Information Technologies
Decision Date1997-03-06
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

COROMETRICS MODEL 510 AND 511 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 1997-03-06 under 510(k) number K962781. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the COROMETRICS MODEL 510 AND 511 MONITOR?

COROMETRICS MODEL 510 AND 511 MONITOR is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K962781.

When did COROMETRICS MODEL 510 AND 511 MONITOR receive FDA 510(k) clearance?

COROMETRICS MODEL 510 AND 511 MONITOR received FDA 510(k) clearance on 1997-03-06, under 510(k) number K962781.

Who is the listed applicant for COROMETRICS MODEL 510 AND 511 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 510 AND 511 MONITOR?

The FDA product code for COROMETRICS MODEL 510 AND 511 MONITOR is BZQ.

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Other records listing Ge Medical Systems Information Technologies as applicant

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K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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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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