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FDA 510(k)

Steth IO Spot

K-Number: K220196 · 2022-03-24

ApplicantStratoscientific
Decision Date2022-03-24
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Steth IO Spot is a medical device manufactured by Stratoscientific. It received FDA 510(k) clearance on 2022-03-24 under approval number K220196. 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 Spot?

Steth IO Spot is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Stratoscientific. The 510(k) number is K220196.

When was Steth IO Spot approved by the FDA?

Steth IO Spot received FDA 510(k) clearance on 2022-03-24, under approval number K220196.

What company makes Steth IO Spot?

Steth IO Spot is manufactured by Stratoscientific.

What is the FDA product code for Steth IO Spot?

The FDA product code for Steth IO Spot is DQD.

Related Devices (Code: DQD)

K160401Tyto StethoscopeTyto Care , Ltd. K160023Electronic Stethoscope DS301Imediplus, Inc. K160016Steth IOStratoscientific, Inc. K172296Stethee ProM3Dicine Pty , Ltd. K170928CADence SystemAum Cardiovascular, Inc. K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc.

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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