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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 the device name listed in this FDA 510(k) record. The listed applicant is Stratoscientific. It received FDA 510(k) clearance on 2022-03-24 under 510(k) 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. The listed applicant is Stratoscientific. The 510(k) number is K220196.

When did Steth IO Spot receive FDA 510(k) clearance?

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

Who is the listed applicant for Steth IO Spot?

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

What is the FDA product code for Steth IO Spot?

The FDA product code for Steth IO Spot is DQD.

Other records listing Stratoscientific as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160016Steth IO

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

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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