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FDA 510(k)

EASYSCAN MODEL 1.2

K-Number: K111988 · 2011-10-28

ApplicantI-Optics BV
Decision Date2011-10-28
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EASYSCAN MODEL 1.2 is the device name listed in this FDA 510(k) record. The listed applicant is I-Optics BV. It received FDA 510(k) clearance on 2011-10-28 under 510(k) number K111988. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYSCAN MODEL 1.2?

EASYSCAN MODEL 1.2 is a medical device that received FDA 510(k) clearance on 2011-10-28. The listed applicant is I-Optics BV. The 510(k) number is K111988.

When did EASYSCAN MODEL 1.2 receive FDA 510(k) clearance?

EASYSCAN MODEL 1.2 received FDA 510(k) clearance on 2011-10-28, under 510(k) number K111988.

Who is the listed applicant for EASYSCAN MODEL 1.2?

The FDA 510(k) record lists I-Optics BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYSCAN MODEL 1.2?

The FDA product code for EASYSCAN MODEL 1.2 is MYC.

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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.

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