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FDA 510(k)

Steth IO

K-Number: K160016 · 2016-07-15

ApplicantStratoscientific, Inc.
Decision Date2016-07-15
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Steth IO is a medical device manufactured by Stratoscientific, Inc.. It received FDA 510(k) clearance on 2016-07-15 under approval number K160016. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steth IO?

Steth IO is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Stratoscientific, Inc.. The 510(k) number is K160016.

When was Steth IO approved by the FDA?

Steth IO received FDA 510(k) clearance on 2016-07-15, under approval number K160016.

What company makes Steth IO?

Steth IO is manufactured by Stratoscientific, Inc..

What is the FDA product code for Steth IO?

The FDA product code for Steth IO is DQD.

Related Devices (Code: DQD)

K160401Tyto StethoscopeTyto Care , Ltd. K160023Electronic Stethoscope DS301Imediplus, Inc. K172296Stethee ProM3Dicine Pty , Ltd. K170928CADence SystemAum Cardiovascular, Inc. K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. K162589Adscope 658 Electronic StethoscopeAmerican Diagnostic Corp.

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.

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