AcuPebble SA
K-Number: K210480 · 2021-07-06
ApplicantAcurable Limited
Decision Date2021-07-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AcuPebble SA is a medical device manufactured by Acurable Limited. It received FDA 510(k) clearance on 2021-07-06 under approval number K210480. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AcuPebble SA?
AcuPebble SA is a medical device that received FDA 510(k) clearance on 2021-07-06. It is manufactured by Acurable Limited. The 510(k) number is K210480.
When was AcuPebble SA approved by the FDA?
AcuPebble SA received FDA 510(k) clearance on 2021-07-06, under approval number K210480.
What company makes AcuPebble SA?
AcuPebble SA is manufactured by Acurable Limited.
What is the FDA product code for AcuPebble SA?
The FDA product code for AcuPebble SA is MNR.
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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.