Name: Predicase
Price: 199 USD

K-number	K190208
Device name	Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Applicant	Diversatek Healthcare
Product code	FFX
Device class	Class II
Decision date	Oct 3, 2019
Decision	Substantially Equivalent
Regulation	876.1725

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

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