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FDA 510(k)

ISCREEN VISION SCREENER

K-Number: K102651 · 2011-01-12

ApplicantIscreen Vision, Inc.
Decision Date2011-01-12
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ISCREEN VISION SCREENER is the device name listed in this FDA 510(k) record. The listed applicant is Iscreen Vision, Inc.. It received FDA 510(k) clearance on 2011-01-12 under 510(k) number K102651. 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 ISCREEN VISION SCREENER?

ISCREEN VISION SCREENER is a medical device that received FDA 510(k) clearance on 2011-01-12. The listed applicant is Iscreen Vision, Inc.. The 510(k) number is K102651.

When did ISCREEN VISION SCREENER receive FDA 510(k) clearance?

ISCREEN VISION SCREENER received FDA 510(k) clearance on 2011-01-12, under 510(k) number K102651.

Who is the listed applicant for ISCREEN VISION SCREENER?

The FDA 510(k) record lists Iscreen Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISCREEN VISION SCREENER?

The FDA product code for ISCREEN VISION SCREENER is HKI.

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Official Source

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