Product code DRG
- Device name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2910
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026-01-22 |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025-10-02 |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025-06-04 |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024-11-12 |
| K241101 | BioButton System | Biointellisense, Inc. | 2024-09-26 |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024-06-03 |
| K223711 | ANNE One | Sibel Health, Inc. | 2023-08-10 |
| K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023-05-15 |
| K223073 | Alio | Alio, Inc. | 2023-03-17 |
| K222398 | Care Team Portal | Vivify Health, Inc. | 2023-02-06 |
| K212957 | BioButton System | Biolntellisense, Inc. | 2022-12-12 |
| K221530 | ANNE Pediatric | Sibel, Inc. | 2022-11-22 |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022-07-15 |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | 2022-06-23 |
| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | 2022-03-24 |
| K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022-02-03 |
| K211305 | ANNE One | Sibel, Inc. | 2021-09-14 |
| K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | 2021-07-21 |
| K200690 | LifeSignals ECG Remote Monitoring Patch Platform | Lifesignals, Inc. | 2020-07-15 |
| K191620 | Vitls Platform | Vitls, Inc. | 2020-06-01 |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | Vitalconnect, Inc. | 2020-04-20 |
| K192875 | Philips Biosensor BX100 | Philips Medical Systems | 2020-04-16 |
| K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 | Vitalconnect, Inc. | 2020-02-06 |
| K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | VivaLNK, Inc. | 2020-01-07 |
| K191614 | BioSticker System | Biointellisense, Inc. | 2019-12-18 |
| K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | 2019-06-12 |
| K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | Vitalconnect, Inc. | 2019-06-07 |
| K183078 | VitalConnect Platform, VitalPatch Biosensor | Vitalconnect, Inc. | 2019-03-07 |
| K182297 | Surveyor S2 | Mortara Instrument, Inc. | 2019-01-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3944670047010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700068020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700064010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700063010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700051020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048100 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048090 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048080 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048070 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048060 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048050 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048030 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3944060056010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945000030010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300046010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945600013020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048040 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| G012BRCA02 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCA05 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCD02 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP01 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP02 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP03 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCS02 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCT01 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BSPS01 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |