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) (10) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (10) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (10) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (6) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (4) Detector And Alarm, Arrhythmia (DSI) (3) Monitor, St Segment With Alarm (MLD) (3) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (3) System, Network And Communication, Physiological Monitors (MSX) (3)

Premarket Exempt

Clear

WVSM Wireless Vital Signs Monitor - B3943900004000 Catalog Number : 390-0004-00

Device Description : WVSM Management Suite - PC

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DXN, DRG, DQA, MWI

Prescription Use : Yes

Device Count : 1

Athena GTX Device Management Suite (ADMS) Software - B3943900008000 Catalog Number : 390-0008-00

Device Description : Athena GTX Device Management Suite - PC

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MLD, DQA, DXN, DSI, MWI, MHX, DRG, MSX

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3943950006000 Catalog Number : 395-0006-00

Device Description : WVSM Management Suite - iOS

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

Athena GTX Device Management Suite (ADMS) Software - B3943950009000 Catalog Number : 395-0009-00

Device Description : Athena GTX Device Management Suite - iOS

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MLD, DQA, DXN, DSI, MWI, MHX, DRG, MSX

Prescription Use : Yes

Device Count : 1

Athena GTX Device Management Suite (ADMS) Software - B3943950010000 Catalog Number : 395-0010-00

Device Description : Athena GTX Device Management Suite - Android

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DRG, MLD, DQA, DXN, DSI, MWI, MHX, MSX

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3944060005010 Catalog Number : 406-0005-01

Device Description : BP Cuff Clip

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 - B3944670006010 Catalog Number : 467-0006-01

Device Description : A/C Power Cord

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 - B3944670019010 Catalog Number : 467-0019-01

Device Description : WVSM Power Cord (US)

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 - B3944670019020 Catalog Number : 467-0019-02

Device Description : A/C Power Cord

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 - B3944670036010 Catalog Number : 467-0006-01

Device Description : A/C Power Cord - Israel

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DXN, DRG, DQA, MWI

Prescription Use : Yes

Device Count : 1

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