FDA 510(k)

IQSense Flow Sensor Mouthpiece

Número K: K150515 · 2016-01-12

Data da decisão2016-01-12

Código do produtoBZG

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

IQSense Flow Sensor Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K150515. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IQSense Flow Sensor Mouthpiece?

IQSense Flow Sensor Mouthpiece is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K150515.

When did IQSense Flow Sensor Mouthpiece receive FDA 510(k) clearance?

IQSense Flow Sensor Mouthpiece received FDA 510(k) clearance on 2016-01-12, under 510(k) number K150515.

Who is the listed applicant for IQSense Flow Sensor Mouthpiece?

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

What is the FDA product code for IQSense Flow Sensor Mouthpiece?

The FDA product code for IQSense Flow Sensor Mouthpiece is BZG.

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