ECG Telemetry System
FDA 510(k) K772000 · Mennen Greatbatch Electonics
510(k) numberK772000
Submission
- Device name
- ECG Telemetry System
- Applicant
- Mennen Greatbatch Electonics
Mchenry, IL, US - Received
- October 21, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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| K252984 | Perin Health System (PHD80060-2)DRG · Traditional | Perin Health Devices, LLC | 01/22/2026SE |
| K252440 | EasyTeleMed (2.0.2)DRG · Traditional | Ingeniars S.R.L. | 10/02/2025SE |
| K250259 | TeleRehab Aermos Cardiopulmonary RehabilitationDRG · Traditional | The ScottCare Corporation | 06/04/2025SE |
| K243837 | iBSMDRG · Traditional | Iorbit Digital Technologies Private Limited | 05/16/2025SE |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550)DRG · Traditional | Lifesignals, Inc. | 11/12/2024SE |
| K241101 | BioButton SystemDRG · Traditional | Biointellisense, Inc. | 09/26/2024SE |
| K240251 | ANNE ChestDRG · Traditional | Sibel Health, Inc. | 06/03/2024SE |
| K223711 | ANNE OneDRG · Traditional | Sibel Health, Inc. | 08/10/2023SE |
| K220526 | HD+12, HD+15DRG · Traditional | Cardioline S.P.A | 05/15/2023SE |
More from Cardioline S.P.A
| 510(k) | Device | Decision |
|---|---|---|
| K770832 | Portascope IIDPS · Traditional | 06/03/1977SE |
| K770279 | Monitor, Portable, Part #431-010DXJ · Traditional | 02/24/1977SE |
| K770247 | D.C. Amplifier ModuleDRQ · Traditional | 02/14/1977SE |
| K770246 | Isolated EEG Amplifier ModuleGWQ · Traditional | 02/14/1977SE |
| K770245 | Abdominal Fetal ECG ModuleKXN · Traditional | 02/14/1977SE |
Questions and answers
When was ECG Telemetry System cleared by the FDA?
ECG Telemetry System (K772000) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 32 days after the submission was received.
What is the product code of K772000?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.