RMG-9 9 Remote Monitor Access. for G-2000 Electro
FDA 510(k) K851628 · Eaton Medical Group
510(k) numberK851628
Submission
- Device name
- RMG-9 9 Remote Monitor Access. for G-2000 Electro
- Applicant
- Eaton Medical Group
Eaton, MI, US - Received
- April 18, 1985
- Decision date
- June 27, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K851623 | Model TRC-40 Telemetry Reciever ModuleDXH · Traditional | 01/22/1986SE |
| 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 |
| 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 RMG-9 9 Remote Monitor Access. for G-2000 Electro cleared by the FDA?
RMG-9 9 Remote Monitor Access. for G-2000 Electro (K851628) received a 510(k) decision of Substantially Equivalent on June 27, 1985, 70 days after the submission was received.
What is the product code of K851628?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.