PURSUANT HEALTH

FDA Device Registration & Listing · Alpharetta, GA, US · Registration 3012540196

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012540196
FEI Number
3012540196
Entity Name
PURSUANT HEALTH
City/State/Country
Alpharetta, GA, US
Establishment Address
11350 Old Roswell Rd, Suite 900, Alpharetta, GA 30009, US
Establishment Type(s)
Remanufacture Medical Device,Manufacture Medical Device
Owner / Operator
Pursuant Health (Owner Number: 10024427)
Owner / Operator Contact Address
11350 Old Roswell Rd, Suite 900, Alpharetta, GA 30009, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230996
PMA Number
N/A

All Registered Proprietary Names

SoloHealth Station EyeSite Pursuant Health Kiosk

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-01-07
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2013-01-07
HKO Refractometer, Ophthalmic Ophthalmic Class 1 886.1760 2008-01-30
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-01-09
QZP Camera, Ophthalmic, Non-Prescription Ophthalmic Class 2 886.1120 2024-01-09

Official Correspondent

Stephanie Patrick

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pursuant Health
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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3036999955 ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL Largo, MD, US
3019575688 AKTIIA SA Neuchatel, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012540196. Last updated year: 2026. Please use registration number 3012540196 when referencing this establishment in official correspondence.
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