SmartPerfusion
K-Number: K181966 · 2018-08-17
Decision Date2018-08-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SmartPerfusion is a medical device manufactured by Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2018-08-17 under approval number K181966. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartPerfusion?
SmartPerfusion is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Philips Medical Systems Nederlands B.V.. The 510(k) number is K181966.
When was SmartPerfusion approved by the FDA?
SmartPerfusion received FDA 510(k) clearance on 2018-08-17, under approval number K181966.
What company makes SmartPerfusion?
SmartPerfusion is manufactured by Philips Medical Systems Nederlands B.V..
What is the FDA product code for SmartPerfusion?
The FDA product code for SmartPerfusion is OWB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.