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 a medical device manufactured by Pneumacare Limited. It received FDA 510(k) clearance on 2016-03-10 under approval 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. It is manufactured by Pneumacare Limited. The 510(k) number is K151940.
When was Thora-3Di, Model T-01 approved by the FDA?
Thora-3Di, Model T-01 received FDA 510(k) clearance on 2016-03-10, under approval number K151940.
What company makes Thora-3Di, Model T-01?
Thora-3Di, Model T-01 is manufactured by Pneumacare Limited.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.