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FDA 510(k)

CYBOW READER, MODELS 300 & 720

K-Number: K102188 · 2011-08-09

ApplicantDFI Co., Ltd.
Decision Date2011-08-09
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYBOW READER, MODELS 300 & 720 is the device name listed in this FDA 510(k) record. The listed applicant is DFI Co., Ltd.. It received FDA 510(k) clearance on 2011-08-09 under 510(k) number K102188. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYBOW READER, MODELS 300 & 720?

CYBOW READER, MODELS 300 & 720 is a medical device that received FDA 510(k) clearance on 2011-08-09. The listed applicant is DFI Co., Ltd.. The 510(k) number is K102188.

When did CYBOW READER, MODELS 300 & 720 receive FDA 510(k) clearance?

CYBOW READER, MODELS 300 & 720 received FDA 510(k) clearance on 2011-08-09, under 510(k) number K102188.

Who is the listed applicant for CYBOW READER, MODELS 300 & 720?

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

What is the FDA product code for CYBOW READER, MODELS 300 & 720?

The FDA product code for CYBOW READER, MODELS 300 & 720 is KQO.

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Other records listing DFI Co., Ltd. as applicant

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Related Devices (Code: KQO)

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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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