ECG Review Station
FDA 510(k) K942685 · Mortara Instrument, Inc.
510(k) numberK942685
Submission
- Device name
- ECG Review Station
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- June 7, 1994
- Decision date
- August 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K161517 | Mortara Surveyor Patient MonitorMHX · Traditional | 01/11/2017SE |
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| K141020 | Surveyor S4 Mobile MonitorDRG · Traditional | 12/03/2014SE |
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Questions and answers
When was ECG Review Station cleared by the FDA?
ECG Review Station (K942685) received a 510(k) decision of Substantially Equivalent on August 12, 1997, 1,162 days after the submission was received.
What is the product code of K942685?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.