Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY

K-Number: K100427 · 2010-05-28

ApplicantTaidoc Technology Corporation
Decision Date2010-05-28
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2010-05-28 under 510(k) number K100427. 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 FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY?

FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY is a medical device that received FDA 510(k) clearance on 2010-05-28. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K100427.

When did FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY receive FDA 510(k) clearance?

FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY received FDA 510(k) clearance on 2010-05-28, under 510(k) number K100427.

Who is the listed applicant for FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY?

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

What is the FDA product code for FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY?

The FDA product code for FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY is DRG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Taidoc Technology Corporation 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.

K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemK201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemK200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)K190579TD-4183 Blood Glucose Monitoring SystemK182934FORA P100 Blood Pressure Monitoring SystemK180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator

View all 121 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.

↑