FDA.reportPublic FDA data

WVSM Pro, Wireless Vital Signs Monitor Professional

Primary DI
B3944670047010
Brand
WVSM Pro, Wireless Vital Signs Monitor Professional
Company
ATHENA GTX, INC.
Model
WVSM Pro Power Cord
Catalog number
467-0047-01
Device description
Power Cord
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DPSElectrocardiograph
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLContinuous Measurement Thermometer
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DPSElectrocardiographCardiovascular2
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233354000WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.2024-06-26MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3944670047010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
048031913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalMasimo uSpO2 Fingerclip extension (with Ferrite)570-0068-022026-05-27

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06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
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