Model TRC-40 Telemetry Reciever Module
FDA 510(k) K851623 · Eaton Medical Group
510(k) numberK851623
Submission
- Device name
- Model TRC-40 Telemetry Reciever Module
- Applicant
- Eaton Medical Group
Eaton, MI, US - Received
- April 18, 1985
- Decision date
- January 22, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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| K243003 | VitalSigns 1-Lead Holter (VSH101)DXH · Traditional | VitalSigns Technology Co., Ltd. | 06/17/2025SE |
| K233521 | QT ECG (QTERD100)DXH · Special | QT Medical, Inc. | 12/06/2023SE |
| K222842 | V-Patch Cardiac MonitorDXH · Traditional | Shandong Corecare Technology Limited | 10/20/2022SE |
| K220795 | QT ECGDXH · Traditional | QT Medical, Inc. | 09/26/2022SE |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional | Verily Life Sciences, LLC | 07/19/2022SE |
| K220350 | KardiaMobile 6LDXH · Traditional | AliveCor, Inc. | 05/25/2022SE |
More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851624 | Model TT-185 Telemetry TransmitterDXH · Traditional | 01/14/1986SE |
| K851625 | SCX-10 Single Channel Recorder Access. for G-2000DSF · Traditional | 11/19/1985SE |
| K851632 | PCX-100 Patient Input LeadwireDRW · Traditional | 11/08/1985SE |
| K851627 | KBX-20 Outboard Keyboard Access. for G-2000 ElectrDRW · Traditional | 11/08/1985SE |
| K851631 | TMX-C1/C2 Tradmill Controller Access.IOL · Traditional | 07/15/1985SE |
| K851630 | TMX-80 TreadmillIOL · Traditional | 07/09/1985SE |
| K851629 | TMX-70 TreadmillIOL · Traditional | 07/09/1985SE |
| K851628 | RMG-9 9 Remote Monitor Access. for G-2000 ElectroDXJ · Traditional | 06/27/1985SE |
| K851633 | CC-100 Clock/Calander Module Access. for G-2000 ElDPS · Traditional | 06/26/1985SE |
| K851626 | SCX-35 Three Channel Access. for Module G-2000 EleDSF · Traditional | 06/26/1985SE |
Questions and answers
When was Model TRC-40 Telemetry Reciever Module cleared by the FDA?
Model TRC-40 Telemetry Reciever Module (K851623) received a 510(k) decision of Substantially Equivalent on January 22, 1986, 279 days after the submission was received.
What is the product code of K851623?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.