SIVR56-T Kit
FDA 510(k) K133994 · Barco N.V.
510(k) numberK133994
Submission
- Device name
- SIVR56-T Kit
- Applicant
- Barco N.V.
Kortrijk, BE - Received
- December 26, 2013
- Decision date
- December 1, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 SIVR56-T Kit cleared by the FDA?
SIVR56-T Kit (K133994) received a 510(k) decision of Substantially Equivalent on December 1, 2014, 340 days after the submission was received.
What is the product code of K133994?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.