FDA 510(k)

STS

K-Number: K240293 · 2024-09-17

Decision Date2024-09-17

Product CodeBZC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

STS is the device name listed in this FDA 510(k) record. The listed applicant is Techbopulm, Ltd.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240293. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STS?

STS is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Techbopulm, Ltd.. The 510(k) number is K240293.

When did STS receive FDA 510(k) clearance?

STS received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240293.

Who is the listed applicant for STS?

The FDA 510(k) record lists Techbopulm, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STS?

The FDA product code for STS is BZC.

Related Devices (Code: BZC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.