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)

Medaica M1 Telehealth Stethoscope

K-Number: K223166 · 2023-01-19

ApplicantMedaica, Inc.
Decision Date2023-01-19
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medaica M1 Telehealth Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Medaica, Inc.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K223166. 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 Medaica M1 Telehealth Stethoscope?

Medaica M1 Telehealth Stethoscope is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Medaica, Inc.. The 510(k) number is K223166.

When did Medaica M1 Telehealth Stethoscope receive FDA 510(k) clearance?

Medaica M1 Telehealth Stethoscope received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223166.

Who is the listed applicant for Medaica M1 Telehealth Stethoscope?

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

What is the FDA product code for Medaica M1 Telehealth Stethoscope?

The FDA product code for Medaica M1 Telehealth Stethoscope is DQD.

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.

↑