Heartcheck Pen Handheld ECG with Gems Home
FDA 510(k) K111159 · Cardiocomm Solutions, Inc.
510(k) numberK111159
Submission
- Device name
- Heartcheck Pen Handheld ECG with Gems Home
- Applicant
- Cardiocomm Solutions, Inc.
Appollo Beach, FL, US - Received
- April 25, 2011
- Decision date
- December 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| 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 |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS MobileDXH · Traditional | 02/22/2019SE |
| K122632 | Guava IIDPS · Traditional | 02/11/2014SE |
| K121009 | Heartcheck ECG Pen with Gems HomeDPS · Traditional | 05/17/2012SE |
| K111320 | GlobalcardioDSH · Traditional | 10/07/2011SE |
| K033037 | Modification to GlobalcardioDSH · Traditional | 10/31/2003SE |
| K022297 | Global ECG Management System (Gems)DSH · Special | 09/27/2002SE |
| K020366 | Global ECG Management System (Gems)DPS · Traditional | 04/30/2002SE |
| K013354 | GlobalcardioDSH · Traditional | 01/31/2002SE |
Questions and answers
When was Heartcheck Pen Handheld ECG with Gems Home cleared by the FDA?
Heartcheck Pen Handheld ECG with Gems Home (K111159) received a 510(k) decision of Substantially Equivalent on December 22, 2011, 241 days after the submission was received.
What is the product code of K111159?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.