ActiPatch
K-Number: K192234 · 2020-01-31
ApplicantBioelectronics Corporation
Decision Date2020-01-31
Product CodePQY
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
ActiPatch is a medical device manufactured by Bioelectronics Corporation. It received FDA 510(k) clearance on 2020-01-31 under approval number K192234. The device is classified under product code PQY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ActiPatch?
ActiPatch is a medical device that received FDA 510(k) clearance on 2020-01-31. It is manufactured by Bioelectronics Corporation. The 510(k) number is K192234.
When was ActiPatch approved by the FDA?
ActiPatch received FDA 510(k) clearance on 2020-01-31, under approval number K192234.
What company makes ActiPatch?
ActiPatch is manufactured by Bioelectronics Corporation.
What is the FDA product code for ActiPatch?
The FDA product code for ActiPatch is PQY.
Other Devices by Bioelectronics Corporation
Related Devices (Code: PQY)
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.