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FDA 510(k)

MODEL 510 INFANT MONITOR

K-Number: K943308 · 1995-07-25

ApplicantGe Medical Systems Information Technologies
Decision Date1995-07-25
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODEL 510 INFANT 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 1995-07-25 under 510(k) number K943308. 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 MODEL 510 INFANT MONITOR?

MODEL 510 INFANT MONITOR is a medical device that received FDA 510(k) clearance on 1995-07-25. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K943308.

When did MODEL 510 INFANT MONITOR receive FDA 510(k) clearance?

MODEL 510 INFANT MONITOR received FDA 510(k) clearance on 1995-07-25, under 510(k) number K943308.

Who is the listed applicant for MODEL 510 INFANT 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 MODEL 510 INFANT MONITOR?

The FDA product code for MODEL 510 INFANT MONITOR is BZQ.

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Other records listing Ge Medical Systems Information Technologies as applicant

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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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