Name: Predicase
Price: 199 USD

K-number	K252769
Device name	Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
Applicant	Shenzhen Finicare Co., Ltd.
Product code	DXN
Device class	Class II
Decision date	Oct 2, 2025
Decision	Substantially Equivalent
Regulation	870.1130

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)

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