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)

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

K-Number: K041816 · 2004-07-19

ApplicantRtx Healthcare A/S
Decision Date2004-07-19
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY is the device name listed in this FDA 510(k) record. The listed applicant is Rtx Healthcare A/S. It received FDA 510(k) clearance on 2004-07-19 under 510(k) number K041816. 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 RTX3320PSTN WIRELESS TELEHEALTH GATEWAY?

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY is a medical device that received FDA 510(k) clearance on 2004-07-19. The listed applicant is Rtx Healthcare A/S. The 510(k) number is K041816.

When did RTX3320PSTN WIRELESS TELEHEALTH GATEWAY receive FDA 510(k) clearance?

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY received FDA 510(k) clearance on 2004-07-19, under 510(k) number K041816.

Who is the listed applicant for RTX3320PSTN WIRELESS TELEHEALTH GATEWAY?

The FDA 510(k) record lists Rtx Healthcare A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RTX3320PSTN WIRELESS TELEHEALTH GATEWAY?

The FDA product code for RTX3320PSTN WIRELESS 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 Rtx Healthcare A/S 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.

K071953RTX3370K062304DLM112 DAYLINK MONITOR

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.

↑