Supria True64
K-Number: K171738 · 2017-08-18
Decision Date2017-08-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Supria True64 is a medical device manufactured by Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2017-08-18 under approval number K171738. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Supria True64?
Supria True64 is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Hitachi Healthcare Americas Corporation. The 510(k) number is K171738.
When was Supria True64 approved by the FDA?
Supria True64 received FDA 510(k) clearance on 2017-08-18, under approval number K171738.
What company makes Supria True64?
Supria True64 is manufactured by Hitachi Healthcare Americas Corporation.
What is the FDA product code for Supria True64?
The FDA product code for Supria True64 is JAK.
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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.