Tumark Vision
K-Number: K180443 · 2018-03-22
ApplicantSomatex Medical Technologies GmbH
Decision Date2018-03-22
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Tumark Vision is a medical device manufactured by Somatex Medical Technologies GmbH. It received FDA 510(k) clearance on 2018-03-22 under approval number K180443. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tumark Vision?
Tumark Vision is a medical device that received FDA 510(k) clearance on 2018-03-22. It is manufactured by Somatex Medical Technologies GmbH. The 510(k) number is K180443.
When was Tumark Vision approved by the FDA?
Tumark Vision received FDA 510(k) clearance on 2018-03-22, under approval number K180443.
What company makes Tumark Vision?
Tumark Vision is manufactured by Somatex Medical Technologies GmbH.
What is the FDA product code for Tumark Vision?
The FDA product code for Tumark Vision is NEU.
Other Devices by Somatex Medical Technologies GmbH
Related Devices (Code: NEU)
K152510UltraCor Twirl Breast Tissue MarkerBard Peripheral Vascular, Inc.
K161021HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.
K171767Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc.
K170803HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc.
K170026Radiopaque Tissue MarkerViscus Biologics, LLC
K170905Star Tissue MarkerScion Medical Technologies, LLC
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.