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FDA 510(k)

RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO

K-Number: K851628 · 1985-06-27

ApplicantEaton Medical Group
Decision Date1985-06-27
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO is the device name listed in this FDA 510(k) record. The listed applicant is Eaton Medical Group. It received FDA 510(k) clearance on 1985-06-27 under 510(k) number K851628. 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 RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO?

RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO is a medical device that received FDA 510(k) clearance on 1985-06-27. The listed applicant is Eaton Medical Group. The 510(k) number is K851628.

When did RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO receive FDA 510(k) clearance?

RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO received FDA 510(k) clearance on 1985-06-27, under 510(k) number K851628.

Who is the listed applicant for RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO?

The FDA 510(k) record lists Eaton Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO?

The FDA product code for RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO is DXJ.

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Other records listing Eaton Medical Group 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.

K851623MODEL TRC-40 TELEMETRY RECIEVER MODULEK851624MODEL TT-185 TELEMETRY TRANSMITTERK851625SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000K851632PCX-100 PATIENT INPUT LEADWIREK851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTRK851631TMX-C1/C2 TRADMILL CONTROLLER ACCESS.

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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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