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FDA 510(k)

DLM112 DAYLINK MONITOR

K-Number: K062304 · 2006-09-29

ApplicantRtx Healthcare A/S
Decision Date2006-09-29
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DLM112 DAYLINK MONITOR 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 2006-09-29 under 510(k) number K062304. 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 DLM112 DAYLINK MONITOR?

DLM112 DAYLINK MONITOR is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Rtx Healthcare A/S. The 510(k) number is K062304.

When did DLM112 DAYLINK MONITOR receive FDA 510(k) clearance?

DLM112 DAYLINK MONITOR received FDA 510(k) clearance on 2006-09-29, under 510(k) number K062304.

Who is the listed applicant for DLM112 DAYLINK MONITOR?

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 DLM112 DAYLINK MONITOR?

The FDA product code for DLM112 DAYLINK MONITOR 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.

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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.

K071953RTX3370K041816RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

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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