Simpro

FDA Device Registration & Listing · Farmers Branch, TX, US · Registration 3004485927

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
3004485927
FEI Number
3004485927
Entity Name
Simpro
City/State/Country
Farmers Branch, TX, US
Establishment Address
3317 Garden Brook Drive, Farmers Branch, TX 75234, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Simpro (Owner Number: 10023746)
Owner / Operator Contact Address
2018 Primrose Dr, Irving, TX 75063, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K051251
PMA Number
N/A

All Registered Proprietary Names

NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit NatureSpirit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2017-07-27
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2017-01-30
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-06-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
DQA Oximeter Cardiovascular Class 2 870.2700 2010-05-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2010-05-20
DQA Oximeter Cardiovascular Class 2 870.2700 2019-03-27
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2017-12-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-02-24
DQA Oximeter Cardiovascular Class 2 870.2700 2019-03-27
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2019-08-02
DQA Oximeter Cardiovascular Class 2 870.2700 2010-05-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2015-04-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2007-12-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-12

Official Correspondent

Ziqiang Hong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Simpro
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
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004485927. Last updated year: 2026. Please use registration number 3004485927 when referencing this establishment in official correspondence.
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