510(k) K231424
K231424 is an FDA 510(k) premarket notification submitted by Heartbeam, Inc. for the device "HeartBeam AIMIGo(TM) System". The FDA issued a decision of Substantially Equivalent on December 13, 2024. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Heartbeam, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2024
- Date Received
- May 17, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory (Without Analysis)
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type