SmartPerfusion
FDA 510(k) K181966 · Philips Medical Systems Nederlands B.V.
510(k) numberK181966
Submission
- Device name
- SmartPerfusion
- Applicant
- Philips Medical Systems Nederlands B.V.
Best Noord-Brabant, NL - Received
- July 23, 2018
- Decision date
- August 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SmartPerfusion cleared by the FDA?
SmartPerfusion (K181966) received a 510(k) decision of Substantially Equivalent on August 17, 2018, 25 days after the submission was received.
What is the product code of K181966?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.