Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007413079

FEI Number

3007413079

Entity Name

ATHENA GTX

City/State/Country

Johnston, IA, US

Establishment Address

5900 NW 86th St Ste 300, Johnston, IA 50131, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Athena GTX (Owner Number: 10034326)

Owner / Operator Contact Address

5900 NW 86th Street, Suite 300, Johnston, IA 50131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173203

PMA Number

N/A

All Registered Proprietary Names

WVSM Pro (Series) (500-0030-XX) WVSM ADMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-02-12
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-02-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-02-12
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2025-02-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-02-12
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-02-12
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2025-02-12
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-02-12
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2025-02-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-11-23
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2010-11-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2018-04-18
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2018-04-18
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-04-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-04-18
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2018-04-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-04-18
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2018-04-18
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-04-18

Official Correspondent

Sean Mahoney

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Athena GTX

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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3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007413079. Last updated year: 2026. Please use registration number 3007413079 when referencing this establishment in official correspondence.