AT 030
K-Number: K180839 · 2018-06-07
ApplicantCarl Zeiss Meditec, AG
Decision Date2018-06-07
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
AT 030 is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2018-06-07 under approval number K180839. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AT 030?
AT 030 is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K180839.
When was AT 030 approved by the FDA?
AT 030 received FDA 510(k) clearance on 2018-06-07, under approval number K180839.
What company makes AT 030?
AT 030 is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for AT 030?
The FDA product code for AT 030 is HKY.
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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.