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FDA 510(k)

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable

K-Number: K214046 · 2022-05-25

ApplicantStryker
Decision Date2022-05-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K214046. 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 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable?

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Stryker. The 510(k) number is K214046.

When did 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable receive FDA 510(k) clearance?

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable received FDA 510(k) clearance on 2022-05-25, under 510(k) number K214046.

Who is the listed applicant for 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable?

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

What is the FDA product code for 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable?

The FDA product code for 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable is GCJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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