FDA 510(k)

WeSensor

K-Number: K230916 · 2023-10-10

Decision Date2023-10-10

Product CodeMUH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

WeSensor is the device name listed in this FDA 510(k) record. The listed applicant is Picopack, Inc.. It received FDA 510(k) clearance on 2023-10-10 under 510(k) 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. The listed applicant is Picopack, Inc.. The 510(k) number is K230916.

When did WeSensor receive FDA 510(k) clearance?

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

Who is the listed applicant for WeSensor?

The FDA 510(k) record lists Picopack, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WeSensor?

The FDA product code for WeSensor is MUH.

Other records listing Picopack, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241963WERAY

Related Devices (Code: MUH)

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.