Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020115

FEI Number

3020115

Entity Name

PARKS MEDICAL ELECTRONICS, INC.

City/State/Country

ALOHA, OR, US

Establishment Address

19460 SW SHAW ST, ALOHA, OR 97007, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PARKS MEDICAL ELECTRONICS, INC. (Owner Number: 9930003)

Owner / Operator Contact Address

19460 SOUTH WEST SHAW, --, Aloha, OR 97007, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K944495

PMA Number

N/A

All Registered Proprietary Names

641-A; 614-B; 611-L; 917 811-B; 811-BL; 811-BTS; 842; 909; 841-A; 801-B; 812; 840; 915-BL; 806-CB; 810-A; 810-B 2100-SX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEK	Monitor, Heart Sound, Fetal, Ultrasonic	Obstetrics/Gynecology	Class 2	884.2660	2008-03-20
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2008-03-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2008-03-20
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2008-03-20
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2008-03-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2008-03-20

Official Correspondent

Chris Elkins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PARKS MEDICAL ELECTRONICS, INC.

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
K903633	Transonic Systems, Inc.	ADVANCE LASER FLOWMETER, ALF 21	1990-10-09
K182494	Laser Associated Sciences, Inc.	FlowMet-R	2019-02-27
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

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.
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual

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3006169981	Kaz USA, Inc., A Helen of Troy Company	MARLBOROUGH, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020115. Last updated year: 2026. Please use registration number 3020115 when referencing this establishment in official correspondence.