HAAG-STREIT FUNDUS MODULE 300
K-Number: K163021 · 2017-04-11
ApplicantOptomed OY
Decision Date2017-04-11
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
HAAG-STREIT FUNDUS MODULE 300 is a medical device manufactured by Optomed OY. It received FDA 510(k) clearance on 2017-04-11 under approval number K163021. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HAAG-STREIT FUNDUS MODULE 300?
HAAG-STREIT FUNDUS MODULE 300 is a medical device that received FDA 510(k) clearance on 2017-04-11. It is manufactured by Optomed OY. The 510(k) number is K163021.
When was HAAG-STREIT FUNDUS MODULE 300 approved by the FDA?
HAAG-STREIT FUNDUS MODULE 300 received FDA 510(k) clearance on 2017-04-11, under approval number K163021.
What company makes HAAG-STREIT FUNDUS MODULE 300?
HAAG-STREIT FUNDUS MODULE 300 is manufactured by Optomed OY.
What is the FDA product code for HAAG-STREIT FUNDUS MODULE 300?
The FDA product code for HAAG-STREIT FUNDUS MODULE 300 is HKI.
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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.