Monitor, Portable, Part #431-010
FDA 510(k) K770279 · Mennen Greatbatch Electonics
510(k) numberK770279
Submission
- Device name
- Monitor, Portable, Part #431-010
- Applicant
- Mennen Greatbatch Electonics
Mchenry, IL, US - Received
- February 14, 1977
- Decision date
- February 24, 1977
- 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 |
|---|---|---|
| K772000 | ECG Telemetry SystemDRG · Traditional | 11/22/1977SE |
| K770832 | Portascope IIDPS · Traditional | 06/03/1977SE |
| 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 Monitor, Portable, Part #431-010 cleared by the FDA?
Monitor, Portable, Part #431-010 (K770279) received a 510(k) decision of Substantially Equivalent on February 24, 1977, 10 days after the submission was received.
What is the product code of K770279?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.