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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Optomed OY. It received FDA 510(k) clearance on 2017-04-11 under 510(k) 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. The listed applicant is Optomed OY. The 510(k) number is K163021.

When did HAAG-STREIT FUNDUS MODULE 300 receive FDA 510(k) clearance?

HAAG-STREIT FUNDUS MODULE 300 received FDA 510(k) clearance on 2017-04-11, under 510(k) number K163021.

Who is the listed applicant for HAAG-STREIT FUNDUS MODULE 300?

The FDA 510(k) record lists Optomed OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAAG-STREIT FUNDUS MODULE 300?

The FDA product code for HAAG-STREIT FUNDUS MODULE 300 is HKI.

Other records listing Optomed OY as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

Related Devices (Code: HKI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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