1NEED Pro
K-Number: K243472 · 2025-03-19
ApplicantCampomats S.R.L.
Decision Date2025-03-19
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
1NEED Pro is a medical device manufactured by Campomats S.R.L.. It received FDA 510(k) clearance on 2025-03-19 under approval number K243472. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 1NEED Pro?
1NEED Pro is a medical device that received FDA 510(k) clearance on 2025-03-19. It is manufactured by Campomats S.R.L.. The 510(k) number is K243472.
When was 1NEED Pro approved by the FDA?
1NEED Pro received FDA 510(k) clearance on 2025-03-19, under approval number K243472.
What company makes 1NEED Pro?
1NEED Pro is manufactured by Campomats S.R.L..
What is the FDA product code for 1NEED Pro?
The FDA product code for 1NEED Pro is QAI.
Related Devices (Code: QAI)
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.