Endophys Blood Pressure Monitor model BPM-30— 510(k) K231586

Name: FDA 510(k) clearance K231586
Creator: U.S. Food and Drug Administration
Published: 2023-11-03

Substantially Equivalent

Endophys Technologies, LLC

FDA 510(k) clearance K231586 for Endophys Blood Pressure Monitor model BPM-30, Substantially Equivalent on 2023-11-03. Applicant: Endophys Technologies, LLC. Device class: 2.

Clearance details

Applicant: Endophys Technologies, LLC
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 2023-05-31
Decision date: 2023-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.