Modification to: Cic Pro Clinical Information Center Central Station
FDA 510(k) K053356 · Ge Medical Systems Information Technologies
510(k) numberK053356
Submission
- Device name
- Modification to: Cic Pro Clinical Information Center Central Station
- Applicant
- Ge Medical Systems Information Technologies
Milwaukee, WI, US - Received
- December 2, 2005
- Decision date
- April 19, 2006
- 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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| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
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Questions and answers
When was Modification to: Cic Pro Clinical Information Center Central Station cleared by the FDA?
Modification to: Cic Pro Clinical Information Center Central Station (K053356) received a 510(k) decision of Substantially Equivalent on April 19, 2006, 138 days after the submission was received.
What is the product code of K053356?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.