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FDA 510(k)

Thora-3Di, Model T-01

K-Number: K151940 · 2016-03-10

ApplicantPneumacare Limited
Decision Date2016-03-10
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Thora-3Di, Model T-01 is the device name listed in this FDA 510(k) record. The listed applicant is Pneumacare Limited. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K151940. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thora-3Di, Model T-01?

Thora-3Di, Model T-01 is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Pneumacare Limited. The 510(k) number is K151940.

When did Thora-3Di, Model T-01 receive FDA 510(k) clearance?

Thora-3Di, Model T-01 received FDA 510(k) clearance on 2016-03-10, under 510(k) number K151940.

Who is the listed applicant for Thora-3Di, Model T-01?

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

What is the FDA product code for Thora-3Di, Model T-01?

The FDA product code for Thora-3Di, Model T-01 is BZQ.

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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.

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