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FDA 510(k)

WeSensor

K-Number: K230916 · 2023-10-10

ApplicantPicopack, Inc.
Decision Date2023-10-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WeSensor is a medical device manufactured by Picopack, Inc.. It received FDA 510(k) clearance on 2023-10-10 under approval number K230916. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WeSensor?

WeSensor is a medical device that received FDA 510(k) clearance on 2023-10-10. It is manufactured by Picopack, Inc.. The 510(k) number is K230916.

When was WeSensor approved by the FDA?

WeSensor received FDA 510(k) clearance on 2023-10-10, under approval number K230916.

What company makes WeSensor?

WeSensor is manufactured by Picopack, Inc..

What is the FDA product code for WeSensor?

The FDA product code for WeSensor is MUH.

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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.

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