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FDA 510(k)

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

K-Number: K233461 · 2024-01-19

ApplicantHi-Dow International, Inc.
Decision Date2024-01-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is a medical device manufactured by Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2024-01-19 under approval number K233461. 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 Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is a medical device that received FDA 510(k) clearance on 2024-01-19. It is manufactured by Hi-Dow International, Inc.. The 510(k) number is K233461.

When was Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) approved by the FDA?

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) received FDA 510(k) clearance on 2024-01-19, under approval number K233461.

What company makes Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is manufactured by Hi-Dow International, Inc..

What is the FDA product code for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

The FDA product code for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) 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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