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FDA 510(k)

SERENO ELECTRONIC STETHOSCOPE

K-Number: K062481 · 2006-10-16

ApplicantPishon High Tech Co., Ltd.
Decision Date2006-10-16
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SERENO ELECTRONIC STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Pishon High Tech Co., Ltd.. It received FDA 510(k) clearance on 2006-10-16 under 510(k) number K062481. 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 SERENO ELECTRONIC STETHOSCOPE?

SERENO ELECTRONIC STETHOSCOPE is a medical device that received FDA 510(k) clearance on 2006-10-16. The listed applicant is Pishon High Tech Co., Ltd.. The 510(k) number is K062481.

When did SERENO ELECTRONIC STETHOSCOPE receive FDA 510(k) clearance?

SERENO ELECTRONIC STETHOSCOPE received FDA 510(k) clearance on 2006-10-16, under 510(k) number K062481.

Who is the listed applicant for SERENO ELECTRONIC STETHOSCOPE?

The FDA 510(k) record lists Pishon High Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERENO ELECTRONIC STETHOSCOPE?

The FDA product code for SERENO ELECTRONIC STETHOSCOPE is DQD.

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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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