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FDA 510(k)

NON-CONTACT TEAR FILM THERMOGRAGH

K-Number: K111771 · 2011-11-30

ApplicantUnited Integrated Services Co., Ltd.
Decision Date2011-11-30
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NON-CONTACT TEAR FILM THERMOGRAGH is the device name listed in this FDA 510(k) record. The listed applicant is United Integrated Services Co., Ltd.. It received FDA 510(k) clearance on 2011-11-30 under 510(k) number K111771. 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 NON-CONTACT TEAR FILM THERMOGRAGH?

NON-CONTACT TEAR FILM THERMOGRAGH is a medical device that received FDA 510(k) clearance on 2011-11-30. The listed applicant is United Integrated Services Co., Ltd.. The 510(k) number is K111771.

When did NON-CONTACT TEAR FILM THERMOGRAGH receive FDA 510(k) clearance?

NON-CONTACT TEAR FILM THERMOGRAGH received FDA 510(k) clearance on 2011-11-30, under 510(k) number K111771.

Who is the listed applicant for NON-CONTACT TEAR FILM THERMOGRAGH?

The FDA 510(k) record lists United Integrated Services Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-CONTACT TEAR FILM THERMOGRAGH?

The FDA product code for NON-CONTACT TEAR FILM THERMOGRAGH is HKI.

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Other records listing United Integrated Services Co., Ltd. as applicant

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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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