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FDA 510(k)

PainTB, PainTJ

K-Number: K203337 · 2022-02-11

Decision Date2022-02-11
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PainTB, PainTJ is a medical device manufactured by Ptech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-11 under approval number K203337. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PainTB, PainTJ?

PainTB, PainTJ is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Ptech Co., Ltd.. The 510(k) number is K203337.

When was PainTB, PainTJ approved by the FDA?

PainTB, PainTJ received FDA 510(k) clearance on 2022-02-11, under approval number K203337.

What company makes PainTB, PainTJ?

PainTB, PainTJ is manufactured by Ptech Co., Ltd..

What is the FDA product code for PainTB, PainTJ?

The FDA product code for PainTB, PainTJ is NHN.

Related Devices (Code: NHN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.