ATHENA GTX, INC.

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Oximeter (DQA) (5) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (5) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (5) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (3) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (2) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (2)

Premarket Exempt

Clear

WVSM Wireless Vital Signs Monitor - B3945700025030 Catalog Number : 570-0025-03

Device Description : BP Extension Hose-3 ft

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700025040 Catalog Number : 570-0025-04

Device Description : BP Extension Hose-4 ft

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DXN, DRG, DQA, MWI

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700025050 Catalog Number : 570-0025-05

Device Description : BP Extension Hose-5 ft

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700047010 Catalog Number : 570-0047-01

Device Description : miniCap Mainstream

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DXN, DQA, DRG, CCK

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700047020 Catalog Number : 570-0047-02

Device Description : miniCap Sidestream

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DXN, DQA, DRG, CCK

Prescription Use : Yes

Device Count : 1

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