Celesteion, PCA-9000A/3
K-Number: K170490 · 2017-06-01
ApplicantToshibamedical Systems Corporation
Decision Date2017-06-01
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Celesteion, PCA-9000A/3 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-01 under approval number K170490. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Celesteion, PCA-9000A/3?
Celesteion, PCA-9000A/3 is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K170490.
When was Celesteion, PCA-9000A/3 approved by the FDA?
Celesteion, PCA-9000A/3 received FDA 510(k) clearance on 2017-06-01, under approval number K170490.
What company makes Celesteion, PCA-9000A/3?
Celesteion, PCA-9000A/3 is manufactured by Toshibamedical Systems Corporation.
What is the FDA product code for Celesteion, PCA-9000A/3?
The FDA product code for Celesteion, PCA-9000A/3 is KPS.
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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.