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FDA 510(k)

TEA Device

K-Number: K230526 · 2023-09-14

Decision Date2023-09-14
Product CodeQHH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TEA Device is the device name listed in this FDA 510(k) record. The listed applicant is Transtimulation Research, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K230526. The device is classified under product code QHH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEA Device?

TEA Device is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Transtimulation Research, Inc.. The 510(k) number is K230526.

When did TEA Device receive FDA 510(k) clearance?

TEA Device received FDA 510(k) clearance on 2023-09-14, under 510(k) number K230526.

Who is the listed applicant for TEA Device?

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

What is the FDA product code for TEA Device?

The FDA product code for TEA Device is QHH.

Other records listing Transtimulation Research, Inc. as applicant

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.

Related Devices (Code: QHH)

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.

Official Source

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