Cleared Traditional

Endophys Blood Pressure Monitor model BPM-30

K231586 · Endophys Technologies, LLC · Cardiovascular

Nov 2023

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K231586 is an FDA 510(k) clearance for the Endophys Blood Pressure Monitor model BPM-30, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Endophys Technologies, LLC (Dallas, US). The FDA issued a Cleared decision on November 3, 2023, 156 days after receiving the submission on May 31, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number	K231586 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2023
Decision Date	November 03, 2023
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF