CellaVision DC-1, CellaVision DC-1 PPA
K-Number: K200595 · 2020-10-16
ApplicantCellaVision AB
Decision Date2020-10-16
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
CellaVision DC-1, CellaVision DC-1 PPA is a medical device manufactured by CellaVision AB. It received FDA 510(k) clearance on 2020-10-16 under approval number K200595. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CellaVision DC-1, CellaVision DC-1 PPA?
CellaVision DC-1, CellaVision DC-1 PPA is a medical device that received FDA 510(k) clearance on 2020-10-16. It is manufactured by CellaVision AB. The 510(k) number is K200595.
When was CellaVision DC-1, CellaVision DC-1 PPA approved by the FDA?
CellaVision DC-1, CellaVision DC-1 PPA received FDA 510(k) clearance on 2020-10-16, under approval number K200595.
What company makes CellaVision DC-1, CellaVision DC-1 PPA?
CellaVision DC-1, CellaVision DC-1 PPA is manufactured by CellaVision AB.
What is the FDA product code for CellaVision DC-1, CellaVision DC-1 PPA?
The FDA product code for CellaVision DC-1, CellaVision DC-1 PPA is JOY.
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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.