FDA.reportPublic FDA data

ATHENA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30074130793007413079ATHENA GTX1N2026-01-015900 NW 86th St Ste 300 Johnston IA US 50131
30187832013018783201ATHENA SURGICAL1N2026-01-016110 Blue Circle Drive Suite 280 Minnetonka MN US 55343
30250242613025024261ATHENA HEALTHCARE PRODUCTS1N2026-01-01346 Orenda Rd Brampton Ontario CA L6T 1G1
30302223603030222360ATHENA INNOVATION (SHENZHEN) TECHNOLOGY CO., LTD.1N2026-01-012301a, Building 2, Wankexingcheng Commercial Center Shenzhen Guangdong CN 518104
30121756293012175629ATHENA MEDICAL PRODUCTS INC.1Y2020-04-2511270 GROOMS RD Suite B Blue Ash OH US 45242
30137232573013723257ATHENA CLUB HOLDINGS, INC1Y2020-04-25899 Glouchester Street Boca Raton FL US 33487

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
2914881896435996K210087Athena Surgical RMUS SystemOTN2021-04-12
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
3110941039035238
3225951360875216
3110941672984510
3225951790763860

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI62024-06-26
MSX22018-03-14
OTN12021-04-12
DQA12016-09-02
BTA12016-01-28

NDC#

PMN#

WiCap

2016-09-02

Athena GTX

Applications#

GUDID#

75 records. Showing 1-40. Next