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FDA 510(k)

eKuore Pro 4T - REF EP0098

K-Number: K212013 · 2021-11-10

ApplicantChip Ideas Electronics S.L.
Decision Date2021-11-10
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

eKuore Pro 4T - REF EP0098 is the device name listed in this FDA 510(k) record. The listed applicant is Chip Ideas Electronics S.L.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212013. 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 eKuore Pro 4T - REF EP0098?

eKuore Pro 4T - REF EP0098 is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Chip Ideas Electronics S.L.. The 510(k) number is K212013.

When did eKuore Pro 4T - REF EP0098 receive FDA 510(k) clearance?

eKuore Pro 4T - REF EP0098 received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212013.

Who is the listed applicant for eKuore Pro 4T - REF EP0098?

The FDA 510(k) record lists Chip Ideas Electronics S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eKuore Pro 4T - REF EP0098?

The FDA product code for eKuore Pro 4T - REF EP0098 is DQD.

Other records listing Chip Ideas Electronics S.L. 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.

K211779ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.K201742eKuore One Wireless Electronic Interface for stethoscopeK203007eKuore Pro SeriesK181882eKuore One electronic interface for stethoscope

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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