Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tyto Stethoscope (OTC)

K-Number: K181612 · 2018-12-17

ApplicantTyto Care , Ltd.
Decision Date2018-12-17
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tyto Stethoscope (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Tyto Care , Ltd.. It received FDA 510(k) clearance on 2018-12-17 under 510(k) number K181612. 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 Tyto Stethoscope (OTC)?

Tyto Stethoscope (OTC) is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K181612.

When did Tyto Stethoscope (OTC) receive FDA 510(k) clearance?

Tyto Stethoscope (OTC) received FDA 510(k) clearance on 2018-12-17, under 510(k) number K181612.

Who is the listed applicant for Tyto Stethoscope (OTC)?

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

What is the FDA product code for Tyto Stethoscope (OTC)?

The FDA product code for Tyto Stethoscope (OTC) is DQD.

Other records listing Tyto Care , Ltd. 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.

K252844Tyto Insights for Wheeze Detection (with PCCP)K252089Tyto Stethoscope (G3)K243567Tyto Insights for Rhonchi DetectionK240555Tyto Insights for Crackles DetectionK232237Tyto Insights for Wheeze DetectionK221614TytoCare Lung Sounds Analyzer

View all 9 devices →

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.

↑