FDA device listing
GEMS Home,HeartCheck ECG Pen
FDA device listing 2024243448 · CardioComm Solutions, Inc.
Key facts
| Proprietary names | GEMS Home,HeartCheck ECG Pen |
|---|---|
| Owner/operator | CardioComm Solutions, Inc. |
| Owner/operator number | 9009563 |
| Premarket submissions | K121009 |
| Product codes | DPS |
| Device names | DPS - Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2340 |
| Review panels | Cardiovascular |
| Registered establishments | CARDIOCOMM SOLUTIONS, INC. |
| Establishment registrations | 9680510 |
| FEI numbers | 3003708031 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database