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FDA 510(k)

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2

K-Number: K212103 · 2021-08-30

ApplicantFona S.R.L
Decision Date2021-08-30
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is the device name listed in this FDA 510(k) record. The listed applicant is Fona S.R.L. It received FDA 510(k) clearance on 2021-08-30 under 510(k) number K212103. 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 StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is a medical device that received FDA 510(k) clearance on 2021-08-30. The listed applicant is Fona S.R.L. The 510(k) number is K212103.

When did StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 receive FDA 510(k) clearance?

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 received FDA 510(k) clearance on 2021-08-30, under 510(k) number K212103.

Who is the listed applicant for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?

The FDA 510(k) record lists Fona S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?

The FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is MUH.

Other records listing Fona S.R.L 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.

K222274FONA XDCK213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephK161131FONA Pan/Ceph

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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