Alivecor Heart Monitor for Iphone
FDA 510(k) K122356 · AliveCor, Inc.
510(k) numberK122356
Submission
- Device name
- Alivecor Heart Monitor for Iphone
- Applicant
- AliveCor, Inc.
San Francisco, CA, US - Received
- August 3, 2012
- Decision date
- November 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
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| K201985 | KardiaAIDQK · Traditional | 11/12/2020SE |
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Questions and answers
When was Alivecor Heart Monitor for Iphone cleared by the FDA?
Alivecor Heart Monitor for Iphone (K122356) received a 510(k) decision of Substantially Equivalent on November 19, 2012, 108 days after the submission was received.
What is the product code of K122356?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.