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FDA 510(k)

IQSense Flow Sensor Mouthpiece

K-Number: K150515 · 2016-01-12

ApplicantSdi Diagnostics, Inc.
Decision Date2016-01-12
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Sdi Diagnostics, Inc.. The 510(k) number is K150515.

When was IQSense Flow Sensor Mouthpiece approved by the FDA?

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

What company makes IQSense Flow Sensor Mouthpiece?

IQSense Flow Sensor Mouthpiece is manufactured by Sdi Diagnostics, Inc..

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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Official Source

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