CARESCAPE Central Station V2
FDA 510(k) K162012 · GE Healthcare
510(k) numberK162012
Submission
- Device name
- CARESCAPE Central Station V2
- Applicant
- GE Healthcare
Milwaukee, WI, US - Received
- July 21, 2016
- Decision date
- September 15, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was CARESCAPE Central Station V2 cleared by the FDA?
CARESCAPE Central Station V2 (K162012) received a 510(k) decision of Substantially Equivalent on September 15, 2016, 56 days after the submission was received.
What is the product code of K162012?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.