PrismaSATE
K-Number: K162887 · 2017-01-06
ApplicantBaxter Healthcare Corporation
Decision Date2017-01-06
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PrismaSATE is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2017-01-06 under approval number K162887. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PrismaSATE?
PrismaSATE is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K162887.
When was PrismaSATE approved by the FDA?
PrismaSATE received FDA 510(k) clearance on 2017-01-06, under approval number K162887.
What company makes PrismaSATE?
PrismaSATE is manufactured by Baxter Healthcare Corporation.
What is the FDA product code for PrismaSATE?
The FDA product code for PrismaSATE is KPO.
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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.