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) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (9) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (9) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (8) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (2) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (1)

Premarket Exempt

Clear

WVSM Wireless Vital Signs Monitor - B3945000001010 Catalog Number : 500-0001-01

Device Description : Wireless Patient Monitor

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 - B3945000001120 Catalog Number : 500-0001-12

Device Description : Wireless Patient Monitor

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

WiCap - B3945000016010 Catalog Number : 500-0016-01

Device Description : Patient Monitor

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : CCK, DQA

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945000025010 Catalog Number : 500-0025-01

Device Description : Carry case/Charger for 10 WVSMs - Black

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 - B3945000025020 Catalog Number : 500-0025-02

Device Description : Carry case/Charger for 10 WVSMs - Olive

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 - B3945000025030 Catalog Number : 500-0025-03

Device Description : Carry case/Charger for 10 WVSMs - Orange

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 - B3945000025040 Catalog Number : 500-0025-04

Device Description : Carry case/Charger for 10 WVSMs - Yellow

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 - B3945000025050 Catalog Number : 500-0025-05

Device Description : Carry case/Charger for 10 WVSMs - Silver

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 - B3945000025060 Catalog Number : 500-0025-06

Device Description : Carry case/Charger for 10 WVSMs - Graphite

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 - B3945000034010 Catalog Number : 500-0034-01

Device Description : Wireless Patient Monitor

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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