FDA 510(k)

RTX3370

K-Number: K071953 · 2007-08-08

Decision Date2007-08-08

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RTX3370 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 2007-08-08 under 510(k) number K071953. 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 RTX3370?

RTX3370 is a medical device that received FDA 510(k) clearance on 2007-08-08. The listed applicant is Rtx Healthcare A/S. The 510(k) number is K071953.

When did RTX3370 receive FDA 510(k) clearance?

RTX3370 received FDA 510(k) clearance on 2007-08-08, under 510(k) number K071953.

Who is the listed applicant for RTX3370?

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 RTX3370?

The FDA product code for RTX3370 is DRG.

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.

K062304DLM112 DAYLINK MONITOR K041816RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

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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.