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FDA 510(k)

DR-2C

K-Number: K844650 · 1985-01-22

ApplicantGeneral Devices
Decision Date1985-01-22
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DR-2C is the device name listed in this FDA 510(k) record. The listed applicant is General Devices. It received FDA 510(k) clearance on 1985-01-22 under 510(k) number K844650. 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 DR-2C?

DR-2C is a medical device that received FDA 510(k) clearance on 1985-01-22. The listed applicant is General Devices. The 510(k) number is K844650.

When did DR-2C receive FDA 510(k) clearance?

DR-2C received FDA 510(k) clearance on 1985-01-22, under 510(k) number K844650.

Who is the listed applicant for DR-2C?

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

What is the FDA product code for DR-2C?

The FDA product code for DR-2C is DXJ.

Other records listing General Devices 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.

K013533EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)K002089ROSETTA-LT/ROSETTA-RXK993202EIM-107 PREP-CHECKK940009GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300K935839GEMSCOM SERIES 5000,K921929GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)

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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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