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FDA 510(k)

VISTA DIGITAL OPTHALMOSCOPE

K-Number: K102412 · 2011-06-23

ApplicantEyequick.Llc
Decision Date2011-06-23
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISTA DIGITAL OPTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Eyequick.Llc. It received FDA 510(k) clearance on 2011-06-23 under 510(k) number K102412. 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 VISTA DIGITAL OPTHALMOSCOPE?

VISTA DIGITAL OPTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 2011-06-23. The listed applicant is Eyequick.Llc. The 510(k) number is K102412.

When did VISTA DIGITAL OPTHALMOSCOPE receive FDA 510(k) clearance?

VISTA DIGITAL OPTHALMOSCOPE received FDA 510(k) clearance on 2011-06-23, under 510(k) number K102412.

Who is the listed applicant for VISTA DIGITAL OPTHALMOSCOPE?

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

What is the FDA product code for VISTA DIGITAL OPTHALMOSCOPE?

The FDA product code for VISTA DIGITAL OPTHALMOSCOPE is HKI.

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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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