HEARTBEAM
Matched from indexed company URL: Heartbeam, Inc.
FDA Registration(s)#
Registration, FEI, Name table| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|
| 3035371769 | 3035371769 | HEARTBEAM | 1 | N | 2026-01-01 | 2118 Walsh Ave Ste 210 Santa Clara CA US 95050 |
Registered Device Listings#
Registration key, Listing key, Premarket submission table| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|
| 336589 | 1557907028 | K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | DXH | 2025-12-08 |
| 336589 | 1057485234 | K231424 | HeartBeam AIMIGo(TM) System | MWJ | 2024-12-13 |
Product Codes Associated With Registrations#
Product code, Registration listing records, Latest decision table| Product code | Registration listing records | Latest decision |
|---|
| DXH | 1 | 2025-12-08 |
| MWJ | 1 | 2024-12-13 |
PMN#
2024-12-13
Heartbeam, Inc.