FDA 510(k)

RTX 3371

K-Number: K090886 · 2009-04-15

Decision Date2009-04-15

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RTX 3371 is the device name listed in this FDA 510(k) record. The listed applicant is Tunstall Healthcare. It received FDA 510(k) clearance on 2009-04-15 under 510(k) number K090886. 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 RTX 3371?

RTX 3371 is a medical device that received FDA 510(k) clearance on 2009-04-15. The listed applicant is Tunstall Healthcare. The 510(k) number is K090886.

When did RTX 3371 receive FDA 510(k) clearance?

RTX 3371 received FDA 510(k) clearance on 2009-04-15, under 510(k) number K090886.

Who is the listed applicant for RTX 3371?

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

What is the FDA product code for RTX 3371?

The FDA product code for RTX 3371 is DRG.

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, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.