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FDA 510(k)

AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A

K-Number: K010729 · 2001-10-26

ApplicantAndromed, Inc.
Decision Date2001-10-26
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A is the device name listed in this FDA 510(k) record. The listed applicant is Andromed, Inc.. It received FDA 510(k) clearance on 2001-10-26 under 510(k) number K010729. 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 AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A?

AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Andromed, Inc.. The 510(k) number is K010729.

When did AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A receive FDA 510(k) clearance?

AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A received FDA 510(k) clearance on 2001-10-26, under 510(k) number K010729.

Who is the listed applicant for AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A?

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 AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A?

The FDA product code for AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A is DQD.

Related Clinical Trials

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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 LINKK021389BIOLOGICAL SOUND MONITOR (BSM) SENSORK001306STETHOS, 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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