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FDA 510(k)

MONITOR, PORTABLE, PART #431-010

K-Number: K770279 · 1977-02-24

ApplicantMennen Greatbatch Electonics
Decision Date1977-02-24
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, PORTABLE, PART #431-010 is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Greatbatch Electonics. It received FDA 510(k) clearance on 1977-02-24 under 510(k) number K770279. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, PORTABLE, PART #431-010?

MONITOR, PORTABLE, PART #431-010 is a medical device that received FDA 510(k) clearance on 1977-02-24. The listed applicant is Mennen Greatbatch Electonics. The 510(k) number is K770279.

When did MONITOR, PORTABLE, PART #431-010 receive FDA 510(k) clearance?

MONITOR, PORTABLE, PART #431-010 received FDA 510(k) clearance on 1977-02-24, under 510(k) number K770279.

Who is the listed applicant for MONITOR, PORTABLE, PART #431-010?

The FDA 510(k) record lists Mennen Greatbatch Electonics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONITOR, PORTABLE, PART #431-010?

The FDA product code for MONITOR, PORTABLE, PART #431-010 is DXJ.

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Other records listing Mennen Greatbatch Electonics as applicant

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.

K772000ECG TELEMETRY SYSTEMK770832PORTASCOPE IIK770247D.C. AMPLIFIER MODULEK770246ISOLATED EEG AMPLIFIER MODULEK770245ABDOMINAL FETAL ECG MODULE

Related Devices (Code: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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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