| Primary Device ID | B210AC0190 |
| NIH Device Record Key | 70c33eff-daae-42d1-9a2d-90d9bb16820a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KardiaMobile 6L |
| Version Model Number | AC-019 |
| Company DUNS | 078523613 |
| Company Name | ALIVECOR, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com | |
| Phone | (855) 338 8800 |
| support@alivecor.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B210AC0190 [Primary] |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-11 |
| Device Publish Date | 2020-05-01 |
| B210AC0290 - K1000 | 2025-03-26 K1000 is a 3-electrode personal EKG device that is capable of recording a 6-Lead EKG, which provides the healthcare professional |
| B210AC0270 - Kardia 12L | 2024-08-21 Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using softwar |
| B210AC0110 - KardiaBand System | 2024-04-01 The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, st |
| B210AC0210 - KardiaMobile Card | 2022-07-21 The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, tran |
| B210AC0190 - KardiaMobile 6L | 2020-05-11 |
| B210AC0190 - KardiaMobile 6L | 2020-05-11 |
| B210AC0090 - Kardia Mobile | 2018-07-06 |