Mac 600 Resting ECG Analysis System
FDA 510(k) K103765 · Ge Medical Systems Information Technologies, Inc.
510(k) numberK103765
Submission
- Device name
- Mac 600 Resting ECG Analysis System
- Applicant
- Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US - Received
- December 23, 2010
- Decision date
- May 17, 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 |
|---|---|---|
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | 07/24/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | 01/26/2026SE |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | 07/09/2025SE |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…DQK · Special | 12/12/2024SE |
| K233810 | Portrait VSMMWI · Traditional | 04/25/2024SE |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application…MWI · Traditional | 03/20/2024SE |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK · Traditional | 12/13/2023SE |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services…MWI · Traditional | 08/11/2023SE |
| K230145 | One-CufDXQ · Traditional | 03/14/2023SE |
| K222586 | Mural Clinical ViewerMHX · Traditional | 12/21/2022SE |
Questions and answers
When was Mac 600 Resting ECG Analysis System cleared by the FDA?
Mac 600 Resting ECG Analysis System (K103765) received a 510(k) decision of Substantially Equivalent on May 17, 2011, 145 days after the submission was received.
What is the product code of K103765?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.