Carescape Central Station (Formally Known AS Cic Pro)
FDA 510(k) K133882 · Ge Medical Systems Information Technologies, Inc.
510(k) numberK133882
Submission
- Device name
- Carescape Central Station (Formally Known AS Cic Pro)
- Applicant
- Ge Medical Systems Information Technologies, Inc.
Milwaukee, WI, US - Received
- December 20, 2013
- Decision date
- April 30, 2014
- 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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| 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 |
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Questions and answers
When was Carescape Central Station (Formally Known AS Cic Pro) cleared by the FDA?
Carescape Central Station (Formally Known AS Cic Pro) (K133882) received a 510(k) decision of Substantially Equivalent on April 30, 2014, 131 days after the submission was received.
What is the product code of K133882?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.