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FDA 510(k)

Keikku Electronic stethoscope

K-Number: K233313 · 2024-04-10

ApplicantLapsi Health Holding B.V.
Decision Date2024-04-10
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Keikku Electronic stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Lapsi Health Holding B.V.. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K233313. 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 Keikku Electronic stethoscope?

Keikku Electronic stethoscope is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Lapsi Health Holding B.V.. The 510(k) number is K233313.

When did Keikku Electronic stethoscope receive FDA 510(k) clearance?

Keikku Electronic stethoscope received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233313.

Who is the listed applicant for Keikku Electronic stethoscope?

The FDA 510(k) record lists Lapsi Health Holding B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Keikku Electronic stethoscope?

The FDA product code for Keikku Electronic 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.

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