CEFALY Connected - OTC, CEFALY Connected - Rx
K-Number: K234029 · 2024-07-18
ApplicantCefaly Technology
Decision Date2024-07-18
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
CEFALY Connected - OTC, CEFALY Connected - Rx is a medical device manufactured by Cefaly Technology. It received FDA 510(k) clearance on 2024-07-18 under approval number K234029. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CEFALY Connected - OTC, CEFALY Connected - Rx?
CEFALY Connected - OTC, CEFALY Connected - Rx is a medical device that received FDA 510(k) clearance on 2024-07-18. It is manufactured by Cefaly Technology. The 510(k) number is K234029.
When was CEFALY Connected - OTC, CEFALY Connected - Rx approved by the FDA?
CEFALY Connected - OTC, CEFALY Connected - Rx received FDA 510(k) clearance on 2024-07-18, under approval number K234029.
What company makes CEFALY Connected - OTC, CEFALY Connected - Rx?
CEFALY Connected - OTC, CEFALY Connected - Rx is manufactured by Cefaly Technology.
What is the FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx?
The FDA product code for CEFALY Connected - OTC, CEFALY Connected - Rx is PCC.
Other Devices by Cefaly Technology
Related Devices (Code: PCC)
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.