Name: Predicase
Price: 199 USD

K-number	K201863
Device name	Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
Applicant	Somatex Medical Technologies GmbH
Product code	NEU
Device class	Class II
Decision date	Feb 18, 2021
Decision	Substantially Equivalent
Regulation	878.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape

Everything you need for a 510(k) submission. Nothing you don't.