Slave Monitors DC109 & VS109
FDA 510(k) K810168 · Honeywell, Inc.
510(k) numberK810168
Submission
- Device name
- Slave Monitors DC109 & VS109
- Applicant
- Honeywell, Inc.
Mchenry, IL, US - Received
- January 22, 1981
- Decision date
- February 25, 1981
- 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 |
|---|---|---|
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | 06/19/1990SE |
| K863100 | Cen Sta Mon Ac/Dc Alarm Central Acces Alarm RecorDPS · Traditional | 02/03/1987SE |
| K853501 | Honeywell Electronic Ventilator Ev-ACBK · Traditional | 04/04/1986SE |
| K855125 | Physiological Telemetry Patient Monitoring SystemDRT · Traditional | 03/26/1986SE |
| K851888 | Apm Dispos. Blood Pressure TransducerDRS · Traditional | 08/06/1985SE |
| K851496 | ECG Monitor Model RM102DXJ · Traditional | 07/24/1985SE |
| K850794 | Patient Monitor Model RM-300DTR · Traditional | 04/18/1985SE |
| K851092 | Portable Defibrillator/Monitor Ed 425LDD · Traditional | 04/10/1985SE |
| K834530 | Extension Box EB200DRT · Traditional | 06/01/1984SE |
| K834282 | Ultra Imager 2000IYO · Traditional | 04/23/1984SE |
Questions and answers
When was Slave Monitors DC109 & VS109 cleared by the FDA?
Slave Monitors DC109 & VS109 (K810168) received a 510(k) decision of Substantially Equivalent on February 25, 1981, 34 days after the submission was received.
What is the product code of K810168?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.