AcuPebble OX100
K-Number: K222950 · 2023-02-03
Device Summary
Frequently Asked Questions
What is the AcuPebble OX100?
AcuPebble OX100 is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Acurable Limited. The 510(k) number is K222950.
When did AcuPebble OX100 receive FDA 510(k) clearance?
AcuPebble OX100 received FDA 510(k) clearance on 2023-02-03, under 510(k) number K222950.
Who is the listed applicant for AcuPebble OX100?
The FDA 510(k) record lists Acurable Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AcuPebble OX100?
The FDA product code for AcuPebble OX100 is MNR.
Other records listing Acurable Limited as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MNR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.