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FDA 510(k)

8X-10-6XXX Camera Head

K-Number: K223116 · 2023-02-28

ApplicantSanta Barbara Imaging Systems
Decision Date2023-02-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

8X-10-6XXX Camera Head is the device name listed in this FDA 510(k) record. The listed applicant is Santa Barbara Imaging Systems. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K223116. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8X-10-6XXX Camera Head?

8X-10-6XXX Camera Head is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Santa Barbara Imaging Systems. The 510(k) number is K223116.

When did 8X-10-6XXX Camera Head receive FDA 510(k) clearance?

8X-10-6XXX Camera Head received FDA 510(k) clearance on 2023-02-28, under 510(k) number K223116.

Who is the listed applicant for 8X-10-6XXX Camera Head?

The FDA 510(k) record lists Santa Barbara Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 8X-10-6XXX Camera Head?

The FDA product code for 8X-10-6XXX Camera Head is GCJ.

Related Devices (Code: GCJ)

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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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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