Display Monitor (VD-711RA-VD-712RA)
FDA 510(k) K850343 · Nihon Kohden America, Inc.
510(k) numberK850343
Submission
- Device name
- Display Monitor (VD-711RA-VD-712RA)
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- January 28, 1985
- Decision date
- April 18, 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
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| 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 |
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Questions and answers
When was Display Monitor (VD-711RA-VD-712RA) cleared by the FDA?
Display Monitor (VD-711RA-VD-712RA) (K850343) received a 510(k) decision of Substantially Equivalent on April 18, 1985, 80 days after the submission was received.
What is the product code of K850343?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.