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FDA 510(k)

NEO-TRAK 502 INFANT MONITOR

K-Number: K861407 · 1986-05-14

ApplicantGe Medical Systems Information Technologies
Decision Date1986-05-14
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEO-TRAK 502 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 1986-05-14 under 510(k) number K861407. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-TRAK 502 INFANT MONITOR?

NEO-TRAK 502 INFANT MONITOR is a medical device that received FDA 510(k) clearance on 1986-05-14. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K861407.

When did NEO-TRAK 502 INFANT MONITOR receive FDA 510(k) clearance?

NEO-TRAK 502 INFANT MONITOR received FDA 510(k) clearance on 1986-05-14, under 510(k) number K861407.

Who is the listed applicant for NEO-TRAK 502 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 NEO-TRAK 502 INFANT MONITOR?

The FDA product code for NEO-TRAK 502 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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