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FDA 510(k)

SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS

K-Number: K050670 · 2005-03-30

ApplicantTms Telemedizinische Systeme GmbH
Decision Date2005-03-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS 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 2005-03-30 under 510(k) number K050670. 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 SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS?

SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS is a medical device that received FDA 510(k) clearance on 2005-03-30. The listed applicant is Tms Telemedizinische Systeme GmbH. The 510(k) number is K050670.

When did SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS receive FDA 510(k) clearance?

SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS received FDA 510(k) clearance on 2005-03-30, under 510(k) number K050670.

Who is the listed applicant for SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS?

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 SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS?

The FDA product code for SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS is DXH. This falls under the Hematology category.

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Official Source

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