Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
FDA 510(k) K213357 · Verily Life Sciences, LLC
510(k) numberK213357
Submission
- Device name
- Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
- Applicant
- Verily Life Sciences, LLC
South San Francisco, CA, US - Received
- October 12, 2021
- Decision date
- July 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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| K233521 | QT ECG (QTERD100)DXH · Special | QT Medical, Inc. | 12/06/2023SE |
| K222842 | V-Patch Cardiac MonitorDXH · Traditional | Shandong Corecare Technology Limited | 10/20/2022SE |
| K220795 | QT ECGDXH · Traditional | QT Medical, Inc. | 09/26/2022SE |
| K220350 | KardiaMobile 6LDXH · Traditional | AliveCor, Inc. | 05/25/2022SE |
| K211668 | KardiaMobile CardDXH · Special | AliveCor, Inc. | 11/30/2021SE |
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Questions and answers
When was Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor cleared by the FDA?
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (K213357) received a 510(k) decision of Substantially Equivalent on July 19, 2022, 280 days after the submission was received.
What is the product code of K213357?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.