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FDA 510(k)

ActiPatch(R)

K-Number: K152432 · 2017-02-03

Decision Date2017-02-03
Product CodePQY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ActiPatch(R) is a medical device manufactured by Bioelectronics Corporation. It received FDA 510(k) clearance on 2017-02-03 under approval number K152432. 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(R)?

ActiPatch(R) is a medical device that received FDA 510(k) clearance on 2017-02-03. It is manufactured by Bioelectronics Corporation. The 510(k) number is K152432.

When was ActiPatch(R) approved by the FDA?

ActiPatch(R) received FDA 510(k) clearance on 2017-02-03, under approval number K152432.

What company makes ActiPatch(R)?

ActiPatch(R) is manufactured by Bioelectronics Corporation.

What is the FDA product code for ActiPatch(R)?

The FDA product code for ActiPatch(R) 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.