Image1 S CCU, Image1 S 4U Camera Head
K-Number: K201135 · 2020-09-01
ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2020-09-01
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Image1 S CCU, Image1 S 4U Camera Head is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2020-09-01 under approval number K201135. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Image1 S CCU, Image1 S 4U Camera Head?
Image1 S CCU, Image1 S 4U Camera Head is a medical device that received FDA 510(k) clearance on 2020-09-01. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K201135.
When was Image1 S CCU, Image1 S 4U Camera Head approved by the FDA?
Image1 S CCU, Image1 S 4U Camera Head received FDA 510(k) clearance on 2020-09-01, under approval number K201135.
What company makes Image1 S CCU, Image1 S 4U Camera Head?
Image1 S CCU, Image1 S 4U Camera Head is manufactured by KARL STORZ Endoscopy-America, Inc..
What is the FDA product code for Image1 S CCU, Image1 S 4U Camera Head?
The FDA product code for Image1 S CCU, Image1 S 4U Camera Head is FET.
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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.