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FDA 510(k)

Mytens Model: BW-TSX

K-Number: K171026 · 2017-11-01

ApplicantBewell Connect Corp.
Decision Date2017-11-01
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mytens Model: BW-TSX is a medical device manufactured by Bewell Connect Corp.. It received FDA 510(k) clearance on 2017-11-01 under approval number K171026. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mytens Model: BW-TSX?

Mytens Model: BW-TSX is a medical device that received FDA 510(k) clearance on 2017-11-01. It is manufactured by Bewell Connect Corp.. The 510(k) number is K171026.

When was Mytens Model: BW-TSX approved by the FDA?

Mytens Model: BW-TSX received FDA 510(k) clearance on 2017-11-01, under approval number K171026.

What company makes Mytens Model: BW-TSX?

Mytens Model: BW-TSX is manufactured by Bewell Connect Corp..

What is the FDA product code for Mytens Model: BW-TSX?

The FDA product code for Mytens Model: BW-TSX is NUH.

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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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