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FDA 510(k)

Clio Prime and Clio Pedo

K-Number: K202664 · 2020-11-06

ApplicantSota Precision Optics, Inc. Dba Sota Imaging
Decision Date2020-11-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clio Prime and Clio Pedo is the device name listed in this FDA 510(k) record. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K202664. 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 Clio Prime and Clio Pedo?

Clio Prime and Clio Pedo is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Sota Precision Optics, Inc. Dba Sota Imaging. The 510(k) number is K202664.

When did Clio Prime and Clio Pedo receive FDA 510(k) clearance?

Clio Prime and Clio Pedo received FDA 510(k) clearance on 2020-11-06, under 510(k) number K202664.

Who is the listed applicant for Clio Prime and Clio Pedo?

The FDA 510(k) record lists Sota Precision Optics, Inc. Dba Sota Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clio Prime and Clio Pedo?

The FDA product code for Clio Prime and Clio Pedo is MUH.

Other records listing Sota Precision Optics, Inc. Dba Sota Imaging 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.

K210682SOTA Cloud Imaging

Related Devices (Code: MUH)

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.

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.

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