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FDA 510(k)

MODEL 525 NEO-TRAK NEONATAL RECORDER

K-Number: K823210 · 1982-11-24

ApplicantGe Medical Systems Information Technologies
Decision Date1982-11-24
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 525 NEO-TRAK NEONATAL RECORDER 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 1982-11-24 under 510(k) number K823210. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 525 NEO-TRAK NEONATAL RECORDER?

MODEL 525 NEO-TRAK NEONATAL RECORDER is a medical device that received FDA 510(k) clearance on 1982-11-24. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K823210.

When did MODEL 525 NEO-TRAK NEONATAL RECORDER receive FDA 510(k) clearance?

MODEL 525 NEO-TRAK NEONATAL RECORDER received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823210.

Who is the listed applicant for MODEL 525 NEO-TRAK NEONATAL RECORDER?

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 525 NEO-TRAK NEONATAL RECORDER?

The FDA product code for MODEL 525 NEO-TRAK NEONATAL RECORDER is DSF.

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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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Related Devices (Code: DSF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, Inc.

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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