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FDA 510(k)

OPTOMED SMARTSCOPE, MODEL M3-1 EY1

K-Number: K092056 · 2009-10-01

ApplicantOptomed OY
Decision Date2009-10-01
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTOMED SMARTSCOPE, MODEL M3-1 EY1 is the device name listed in this FDA 510(k) record. The listed applicant is Optomed OY. It received FDA 510(k) clearance on 2009-10-01 under 510(k) number K092056. 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, MODEL M3-1 EY1?

OPTOMED SMARTSCOPE, MODEL M3-1 EY1 is a medical device that received FDA 510(k) clearance on 2009-10-01. The listed applicant is Optomed OY. The 510(k) number is K092056.

When did OPTOMED SMARTSCOPE, MODEL M3-1 EY1 receive FDA 510(k) clearance?

OPTOMED SMARTSCOPE, MODEL M3-1 EY1 received FDA 510(k) clearance on 2009-10-01, under 510(k) number K092056.

Who is the listed applicant for OPTOMED SMARTSCOPE, MODEL M3-1 EY1?

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, MODEL M3-1 EY1?

The FDA product code for OPTOMED SMARTSCOPE, MODEL M3-1 EY1 is HKI.

Related Clinical Trials

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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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 300K132186OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2K110986OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

Official Source

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