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510(k) K231586

Device
Endophys Blood Pressure Monitor model BPM-30
Applicant
Endophys Technologies, LLC
510(k) number
K231586
Product code
DSK
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-03
Date received
2023-05-31
Regulation
870.1110
Classification name
Computer, Blood-Pressure
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Zachary Sowell
Address
1933 E Levee St. Suite B Dallas TX US 75207 75207

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC2016-09-26
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K011865ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTIONZoll Medical Corp2001-07-31
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K002067RADIANALYZER, MODEL 12710Radi Medical Systems AB2001-01-11
K983250INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITORMagnetic Resonance Equipment Corp.1999-12-12
K951226VITALMAX 4000/MINIPACK 3100/3000Pace Tech, Inc.1996-11-21
K943457AS/3 PRESSURE TEMPERATURE MODULE, M-PTDatex Division Instrumentarium Corp.1994-07-27