1788 4K Camera System with Advanced Imaging Modality
K-Number: K230605 · 2023-03-31
ApplicantStryker
Decision Date2023-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
1788 4K Camera System with Advanced Imaging Modality is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2023-03-31 under approval number K230605. 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 1788 4K Camera System with Advanced Imaging Modality?
1788 4K Camera System with Advanced Imaging Modality is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by Stryker. The 510(k) number is K230605.
When was 1788 4K Camera System with Advanced Imaging Modality approved by the FDA?
1788 4K Camera System with Advanced Imaging Modality received FDA 510(k) clearance on 2023-03-31, under approval number K230605.
What company makes 1788 4K Camera System with Advanced Imaging Modality?
1788 4K Camera System with Advanced Imaging Modality is manufactured by Stryker.
What is the FDA product code for 1788 4K Camera System with Advanced Imaging Modality?
The FDA product code for 1788 4K Camera System with Advanced Imaging Modality 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.