CS-series-FP with Optional ROI Accessory CA-100S
K-Number: K182834 · 2019-03-29
ApplicantOmega Medical Imaging, LLC
Decision Date2019-03-29
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CS-series-FP with Optional ROI Accessory CA-100S is a medical device manufactured by Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2019-03-29 under approval number K182834. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CS-series-FP with Optional ROI Accessory CA-100S?
CS-series-FP with Optional ROI Accessory CA-100S is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Omega Medical Imaging, LLC. The 510(k) number is K182834.
When was CS-series-FP with Optional ROI Accessory CA-100S approved by the FDA?
CS-series-FP with Optional ROI Accessory CA-100S received FDA 510(k) clearance on 2019-03-29, under approval number K182834.
What company makes CS-series-FP with Optional ROI Accessory CA-100S?
CS-series-FP with Optional ROI Accessory CA-100S is manufactured by Omega Medical Imaging, LLC.
What is the FDA product code for CS-series-FP with Optional ROI Accessory CA-100S?
The FDA product code for CS-series-FP with Optional ROI Accessory CA-100S is JAA.
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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.