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FDA 510(k)

MODIFIED DR-2C/PMC 100

K-Number: K896153 · 1990-01-19

ApplicantGeneral Devices
Decision Date1990-01-19
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED DR-2C/PMC 100 is the device name listed in this FDA 510(k) record. The listed applicant is General Devices. It received FDA 510(k) clearance on 1990-01-19 under 510(k) number K896153. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED DR-2C/PMC 100?

MODIFIED DR-2C/PMC 100 is a medical device that received FDA 510(k) clearance on 1990-01-19. The listed applicant is General Devices. The 510(k) number is K896153.

When did MODIFIED DR-2C/PMC 100 receive FDA 510(k) clearance?

MODIFIED DR-2C/PMC 100 received FDA 510(k) clearance on 1990-01-19, under 510(k) number K896153.

Who is the listed applicant for MODIFIED DR-2C/PMC 100?

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 MODIFIED DR-2C/PMC 100?

The FDA product code for MODIFIED DR-2C/PMC 100 is DSH.

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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: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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