COMPACT TOUCH Ophthalmic Ultrasound System
K-Number: K180265 · 2018-03-02
ApplicantQuantel Medical
Decision Date2018-03-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
COMPACT TOUCH Ophthalmic Ultrasound System is a medical device manufactured by Quantel Medical. It received FDA 510(k) clearance on 2018-03-02 under approval number K180265. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the COMPACT TOUCH Ophthalmic Ultrasound System?
COMPACT TOUCH Ophthalmic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Quantel Medical. The 510(k) number is K180265.
When was COMPACT TOUCH Ophthalmic Ultrasound System approved by the FDA?
COMPACT TOUCH Ophthalmic Ultrasound System received FDA 510(k) clearance on 2018-03-02, under approval number K180265.
What company makes COMPACT TOUCH Ophthalmic Ultrasound System?
COMPACT TOUCH Ophthalmic Ultrasound System is manufactured by Quantel Medical.
What is the FDA product code for COMPACT TOUCH Ophthalmic Ultrasound System?
The FDA product code for COMPACT TOUCH Ophthalmic Ultrasound System is IYO.
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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.