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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 a medical device manufactured by Santa Barbara Imaging Systems. It received FDA 510(k) clearance on 2023-02-28 under approval 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. It is manufactured by Santa Barbara Imaging Systems. The 510(k) number is K223116.

When was 8X-10-6XXX Camera Head approved by the FDA?

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

What company makes 8X-10-6XXX Camera Head?

8X-10-6XXX Camera Head is manufactured by Santa Barbara Imaging Systems.

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

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

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Official Source

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