510(k) K233354
- Device
- WVSM Pro (Series) (500-0030-XX)
- Applicant
- Athena Gtx, Inc.
- 510(k) number
- K233354
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-26
- Date received
- 2023-09-29
- Regulation
- 870.2300
- Classification name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Sean Mahoney
- Address
- 5900 NW 86th St. Suite 300 Johnson IA US 50131 50131
FDA Registration Numbers
- 2221819
- 9710602
- 3004009431
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Source Documents
Other 510(k) Records For Product Code MWI
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| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024-04-01 |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2024-03-08 |