FDA.reportPublic FDA data

WiCap

Primary DI
B3945000016010
Brand
WiCap
Company
ATHENA GTX, INC.
Model
WiCap
Catalog number
500-0016-01
Device description
Patient Monitor
Published
2017-12-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160582000WiCapAthena Gtx2016-09-02DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3945000016010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
515-288-3360info@athenagtx.com

Regulatory Flags#

DUNS number
048031913
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Charger406-0056-012026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Power Cord467-0047-012026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro500-0030-012026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro Temperature Probe Adapter Cable530-0046-012026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro 12-Lead530-0054-012026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalWVSM Pro 5-Lead530-0054-022026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalMasimo Mainstream (with Ferrite)560-0013-022026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 1' (Dual male connectors)570-0048-012026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 2' (Dual male connectors)570-0048-022026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 3' (Dual male connectors)570-0048-032026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 4' (Dual male connectors)570-0048-042026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 5' (Dual male connectors)570-0048-052026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 6' (Dual male connectors)570-0048-062026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 7' (Dual male connectors)570-0048-072026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 8' (Dual male connectors)570-0048-082026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 9' (Dual male connectors)570-0048-092026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalNIBP Extension 10' (Dual male connectors)570-0048-102026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalNonin Fingerclip extension (with Ferrite)570-0051-022026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalNonin Xpod570-0063-012026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalMasimo uSpO2570-0064-012026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
10885403531521BD Alaris™ ETCO2 Module Model 8300CAREFUSION 303, INC.CCK2026-10-08
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyCCK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyCCK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyCCK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyCCK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26