AliveCor QT Service
FDA 510(k) K212662 · AliveCor, Inc.
510(k) numberK212662
Submission
- Device name
- AliveCor QT Service
- Applicant
- AliveCor, Inc.
Mountain View, CA, US - Received
- August 23, 2021
- Decision date
- April 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was AliveCor QT Service cleared by the FDA?
AliveCor QT Service (K212662) received a 510(k) decision of Substantially Equivalent on April 26, 2022, 246 days after the submission was received.
What is the product code of K212662?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.