Parks Medical Electronics Inc
Aloha, OR, US
PARKS MEDICAL ELECTRONICS, INC. appears in FDA device records in Aloha, OR. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Parks Medical Electronics Inc in 1995.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020115 | 3020115 | PARKS MEDICAL ELECTRONICS, INC. | 19460 SW SHAW ST, ALOHA, OR 97007 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DPWFlowmeter, Blood, Cardiovascular
- HEKMonitor, Heart Sound, Fetal, Ultrasonic
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JOPTransducer, Ultrasonic
- HGLTransducer, Ultrasonic, Obstetric
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0443-2013 | Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities. | Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff. | Class II | Terminated | |
| Z-0673-2008 | Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | Terminated | ||
| Z-0672-2008 | Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | Terminated | ||
| Z-0671-2008 | Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | Terminated | ||
| Z-0670-2008 | Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007 | Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Parks Medical Electronics Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain