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FDA 510(k)

LT-300 HD

K-Number: K160380 · 2016-05-13

ApplicantLutech Industries, Inc.
Decision Date2016-05-13
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LT-300 HD is a medical device manufactured by Lutech Industries, Inc.. It received FDA 510(k) clearance on 2016-05-13 under approval number K160380. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LT-300 HD?

LT-300 HD is a medical device that received FDA 510(k) clearance on 2016-05-13. It is manufactured by Lutech Industries, Inc.. The 510(k) number is K160380.

When was LT-300 HD approved by the FDA?

LT-300 HD received FDA 510(k) clearance on 2016-05-13, under approval number K160380.

What company makes LT-300 HD?

LT-300 HD is manufactured by Lutech Industries, Inc..

What is the FDA product code for LT-300 HD?

The FDA product code for LT-300 HD is HEX.

Other Devices by Lutech Industries, Inc.

K170446LT-300 SD Digital Video Colposcope

Related Devices (Code: HEX)

K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd. K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. K170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc. K182764Biop Digital ColposcopeBiop Medical , Ltd. K181034Pocket Colposcope SystemHadleigh Health Technologies, LLC K190187Gynescope SystemIllumigyn , Ltd.

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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