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FDA 510(k)

I-STETHOS LINK

K-Number: K022298 · 2002-10-01

ApplicantAndromed, Inc.
Decision Date2002-10-01
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

I-STETHOS LINK is the device name listed in this FDA 510(k) record. The listed applicant is Andromed, Inc.. It received FDA 510(k) clearance on 2002-10-01 under 510(k) number K022298. 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 I-STETHOS LINK?

I-STETHOS LINK is a medical device that received FDA 510(k) clearance on 2002-10-01. The listed applicant is Andromed, Inc.. The 510(k) number is K022298.

When did I-STETHOS LINK receive FDA 510(k) clearance?

I-STETHOS LINK received FDA 510(k) clearance on 2002-10-01, under 510(k) number K022298.

Who is the listed applicant for I-STETHOS LINK?

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

What is the FDA product code for I-STETHOS LINK?

The FDA product code for I-STETHOS LINK is DQD.

Related Clinical Trials

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.

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Other records listing Andromed, Inc. 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.

K051779ANDROFLOW - RESPIRATORY RATE MONITORK021389BIOLOGICAL SOUND MONITOR (BSM) SENSORK010729AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533AK001306STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

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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