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FDA 510(k)

EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)

K-Number: K013533 · 2002-01-18

ApplicantGeneral Devices
Decision Date2002-01-18
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) is the device name listed in this FDA 510(k) record. The listed applicant is General Devices. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K013533. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)?

EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is General Devices. The 510(k) number is K013533.

When did EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) receive FDA 510(k) clearance?

EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013533.

Who is the listed applicant for EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)?

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 EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)?

The FDA product code for EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) is DRG.

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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.

K002089ROSETTA-LT/ROSETTA-RXK993202EIM-107 PREP-CHECKK940009GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300K935839GEMSCOM SERIES 5000,K921929GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)K914889GEMSCOM SERIES 3000

View all 13 devices →

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, 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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