FDA.reportPublic FDA data

ATHENA GTX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30074130793007413079ATHENA GTX1N2026-01-015900 NW 86th St Ste 300 Johnston IA US 50131

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B3944060056010WVSM Pro, Wireless Vital Signs Monitor Professional - A/C Power Brick515-288-3360info@athenagtx.com
B3945700048080WVSM Pro, Wireless Vital Signs Monitor Professional - NIBP Extension515-288-3360info@athenagtx.com
B3945700048090WVSM Pro, Wireless Vital Signs Monitor Professional - NIBP Extension515-288-3360info@athenagtx.com
B3945700048100WVSM Pro, Wireless Vital Signs Monitor Professional - NIBP Extension515-288-3360info@athenagtx.com
B3945700051020WVSM Pro, Wireless Vital Signs Monitor Professional - SpO2 extension515-288-3360info@athenagtx.com
B3945700063010WVSM Pro, Wireless Vital Signs Monitor Professional - SpO2 Module515-288-3360info@athenagtx.com
B3945700064010WVSM Pro, Wireless Vital Signs Monitor Professional - SpO2 Module515-288-3360info@athenagtx.com
B3945700068020WVSM Pro, Wireless Vital Signs Monitor Professional - SpO2 extension515-288-3360info@athenagtx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1231111951393379K233354WVSM Pro (Series) (500-0030-XX)MWI2024-06-26
1231111653255346K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapMWI2020-01-29
1231111271618322K173203Athena GTX Device Management Suite (ADMS) SoftwareMSX2018-03-14
1231111608958396K160582WiCapDQA2016-09-02
1231112040705304K153459TACVACBTA2016-01-28
1231111778353124K130957WVSM (WIRLESS VITAL SIGNS MONITOR)MWI2013-04-30
1231112044575681K113165MINI-MEDICMWI2012-02-02
1231111756370587K101674WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0MWI2010-07-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI62024-06-26
MSX22018-03-14
DQA12016-09-02
BTA12016-01-28

PMN#

WiCap

2016-09-02

Athena GTX

GUDID#

67 records. Showing 1-40. Next