Endophys Blood Pressure Monitor— 510(k) K160945

Name: FDA 510(k) clearance K160945
Creator: U.S. Food and Drug Administration
Published: 2016-09-26

Substantially Equivalent

Endophys Holdings, LLC

FDA 510(k) clearance K160945 for Endophys Blood Pressure Monitor, Substantially Equivalent on 2016-09-26. Applicant: Endophys Holdings, LLC. Device class: 2.

Clearance details

Applicant: Endophys Holdings, LLC
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 2016-04-05
Decision date: 2016-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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K190098 — Endophys Pressure Sensing Sheath2019-03-07
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Data sourced from openFDA. This site is unofficial and independent of the FDA.