Centralscope 12
FDA 510(k) K901072 · Marquette Electronics, Inc.
510(k) numberK901072
Submission
- Device name
- Centralscope 12
- Applicant
- Marquette Electronics, Inc.
Milwaukee, WI, US - Received
- March 7, 1990
- Decision date
- August 23, 1990
- 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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|---|---|---|---|
| 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 |
|---|---|---|
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| K971683 | Wireless Lan (Local Area Network) - Wireless EthernetMSX · Traditional | 10/22/1997SE |
| K972199 | Signal-Averaged High Resolution P Wave AnalysisDPS · Traditional | 09/25/1997SE |
| K962547 | Cardioserv PDRO · Traditional | 03/06/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | 02/28/1997SE |
| K962827 | Alarm Display Unit/Pager-Lan System (Adu)DSI · Traditional | 02/24/1997SE |
| K964750 | Eagle 4000 Patient MonitorLOS · Traditional | 02/21/1997SE |
| K962551 | Cardioserv SLDD · Traditional | 11/19/1996ST |
| K960418 | Eagle Patient MonitorDSI · Traditional | 10/02/1996SE |
| K960272 | Eagle 3000/3100 Patient MonitorMLD · Traditional | 10/02/1996SE |
Questions and answers
When was Centralscope 12 cleared by the FDA?
Centralscope 12 (K901072) received a 510(k) decision of Substantially Equivalent on August 23, 1990, 169 days after the submission was received.
What is the product code of K901072?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.