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FDA 510(k)

BIOLOGICAL SOUND MONITOR (BSM) SENSOR

K-Number: K021389 · 2002-10-01

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

Device Summary

BIOLOGICAL SOUND MONITOR (BSM) SENSOR 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 K021389. 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 BIOLOGICAL SOUND MONITOR (BSM) SENSOR?

BIOLOGICAL SOUND MONITOR (BSM) SENSOR 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 K021389.

When did BIOLOGICAL SOUND MONITOR (BSM) SENSOR receive FDA 510(k) clearance?

BIOLOGICAL SOUND MONITOR (BSM) SENSOR received FDA 510(k) clearance on 2002-10-01, under 510(k) number K021389.

Who is the listed applicant for BIOLOGICAL SOUND MONITOR (BSM) SENSOR?

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 BIOLOGICAL SOUND MONITOR (BSM) SENSOR?

The FDA product code for BIOLOGICAL SOUND MONITOR (BSM) SENSOR 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 MONITORK022298I-STETHOS LINKK010729AGILENT 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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