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FDA 510(k)

One Touch

K-Number: K181844 · 2019-04-15

ApplicantThai Nippon Rubber Industry Public Company, Ltd.
Decision Date2019-04-15
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

One Touch is a medical device manufactured by Thai Nippon Rubber Industry Public Company, Ltd.. It received FDA 510(k) clearance on 2019-04-15 under approval number K181844. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One Touch?

One Touch is a medical device that received FDA 510(k) clearance on 2019-04-15. It is manufactured by Thai Nippon Rubber Industry Public Company, Ltd.. The 510(k) number is K181844.

When was One Touch approved by the FDA?

One Touch received FDA 510(k) clearance on 2019-04-15, under approval number K181844.

What company makes One Touch?

One Touch is manufactured by Thai Nippon Rubber Industry Public Company, Ltd..

What is the FDA product code for One Touch?

The FDA product code for One Touch is HIS.

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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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