KODEX EPD System
FDA 510(k) K180940 · Philips Medical Systems Nederland B.V.
510(k) numberK180940
Submission
- Device name
- KODEX EPD System
- Applicant
- Philips Medical Systems Nederland B.V.
Pc Best, NL - Received
- April 10, 2018
- Decision date
- October 24, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was KODEX EPD System cleared by the FDA?
KODEX EPD System (K180940) received a 510(k) decision of Substantially Equivalent on October 24, 2018, 197 days after the submission was received.
What is the product code of K180940?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.