VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
VivaLNK, Inc.
VIVALNK, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011651103 | 3011651103 | VIVALNK, INC. | 1 | N | 2026-01-01 | 51 EAST CAMPBELL AVE., SUITE 160 Campbell CA US 95008 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 182510 | 1770593861 | K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y | FLL | 2022-12-20 |
| 182510 | 1713005674 | K203812 | Oxyfit Pulse Oximeter | DQA | 2022-11-08 |
| 182510 | 2006284314 | K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | DRG | 2020-01-07 |
| 182510 | 1168061878 | K191088 | Checkme O2 Pulse Oximeter | DQA | 2019-12-02 |
| 182510 | 1498916478 | K171062 | BP5S Wireless Blood Pressure Monitor | DXN | 2017-08-01 |
| 182510 | 1808549086 | K162137 | Fever Scout™ Continuous Monitoring thermometer | FLL | 2017-01-19 |
| 182510 | 2010570481 |
Product Codes Associated With Registrations#
PMN#
Fever Scout
VivaLnk Inc.
Fever Scout™ Continuous Monitoring Thermometer
VivaLnk Inc.
GUDID#
Continuous ECG Platform - VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
2022-11-30
Hydrogel Adhesive - Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
2022-09-14
Hydrogel Adhesive - Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
2022-02-11
Hydrogel Adhesive - Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
2022-02-11
Hydrogel Adhesive - Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
2022-02-11
Hydrogel Adhesive - The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
2020-01-30
Enfasmart feversense Adhesive Refill Pack - The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
2018-07-30
Fever Scout Adhesive Refill - The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
2018-07-30
Continuous ECG Platform - VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
2020-01-30
Fever Scout Continuous monitoring thermometer - The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
2018-07-30
Enfasmart feversense Continuous monitoring thermometer - The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
2018-07-30