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FDA 510(k)

INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310

K-Number: K032341 · 2003-08-25

ApplicantSota Precision Optics, Inc.
Decision Date2003-08-25
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 is the device name listed in this FDA 510(k) record. The listed applicant is Sota Precision Optics, Inc.. It received FDA 510(k) clearance on 2003-08-25 under 510(k) number K032341. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310?

INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 is a medical device that received FDA 510(k) clearance on 2003-08-25. The listed applicant is Sota Precision Optics, Inc.. The 510(k) number is K032341.

When did INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 receive FDA 510(k) clearance?

INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 received FDA 510(k) clearance on 2003-08-25, under 510(k) number K032341.

Who is the listed applicant for INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310?

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

What is the FDA product code for INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310?

The FDA product code for INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 is EIA.

Related Clinical Trials

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.

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Other records listing Sota Precision Optics, 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.

K110886CLIO/CLIOSOFTK061175CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES

Related Devices (Code: EIA)

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Official Source

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