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FDA 510(k)

LOOP RECORDER VITAPHONE, 3100 SERIES

K-Number: K053378 · 2006-02-23

ApplicantTms Telemedizinische Systeme GmbH
Decision Date2006-02-23
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOOP RECORDER VITAPHONE, 3100 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Tms Telemedizinische Systeme GmbH. It received FDA 510(k) clearance on 2006-02-23 under 510(k) number K053378. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOOP RECORDER VITAPHONE, 3100 SERIES?

LOOP RECORDER VITAPHONE, 3100 SERIES is a medical device that received FDA 510(k) clearance on 2006-02-23. The listed applicant is Tms Telemedizinische Systeme GmbH. The 510(k) number is K053378.

When did LOOP RECORDER VITAPHONE, 3100 SERIES receive FDA 510(k) clearance?

LOOP RECORDER VITAPHONE, 3100 SERIES received FDA 510(k) clearance on 2006-02-23, under 510(k) number K053378.

Who is the listed applicant for LOOP RECORDER VITAPHONE, 3100 SERIES?

The FDA 510(k) record lists Tms Telemedizinische Systeme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOOP RECORDER VITAPHONE, 3100 SERIES?

The FDA product code for LOOP RECORDER VITAPHONE, 3100 SERIES is DXH. This falls under the Hematology category.

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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.

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