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FDA 510(k)

TV-100

K-Number: K173973 · 2018-07-20

ApplicantBio-Med Devices, Inc.
Decision Date2018-07-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TV-100 is a medical device manufactured by Bio-Med Devices, Inc.. It received FDA 510(k) clearance on 2018-07-20 under approval number K173973. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TV-100?

TV-100 is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by Bio-Med Devices, Inc.. The 510(k) number is K173973.

When was TV-100 approved by the FDA?

TV-100 received FDA 510(k) clearance on 2018-07-20, under approval number K173973.

What company makes TV-100?

TV-100 is manufactured by Bio-Med Devices, Inc..

What is the FDA product code for TV-100?

The FDA product code for TV-100 is CBK.

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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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