Three Channel Monitor Series 6700
FDA 510(k) K830899 · Marquette Electronics, Inc.
510(k) numberK830899
Submission
- Device name
- Three Channel Monitor Series 6700
- Applicant
- Marquette Electronics, Inc.
Mchenry, IL, US - Received
- March 21, 1983
- Decision date
- April 12, 1983
- 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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| K964750 | Eagle 4000 Patient MonitorLOS · Traditional | 02/21/1997SE |
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Questions and answers
When was Three Channel Monitor Series 6700 cleared by the FDA?
Three Channel Monitor Series 6700 (K830899) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 22 days after the submission was received.
What is the product code of K830899?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.