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FDA 510(k)

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2

K-Number: K132186 · 2013-12-18

ApplicantOptomed OY
Decision Date2013-12-18
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 is the device name listed in this FDA 510(k) record. The listed applicant is Optomed OY. It received FDA 510(k) clearance on 2013-12-18 under 510(k) number K132186. 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 OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2?

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 is a medical device that received FDA 510(k) clearance on 2013-12-18. The listed applicant is Optomed OY. The 510(k) number is K132186.

When did OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 receive FDA 510(k) clearance?

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 received FDA 510(k) clearance on 2013-12-18, under 510(k) number K132186.

Who is the listed applicant for OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2?

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 OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2?

The FDA product code for OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 is HKI.

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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 ModuleK163021HAAG-STREIT FUNDUS MODULE 300K110986OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1K092056OPTOMED SMARTSCOPE, MODEL M3-1 EY1

Related Devices (Code: HKI)

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.

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Official Source

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