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FDA 510(k)

STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM

K-Number: K012387 · 2002-04-23

ApplicantStethographics, Inc.
Decision Date2002-04-23
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stethographics, Inc.. It received FDA 510(k) clearance on 2002-04-23 under 510(k) number K012387. The device is classified under product code BZM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM?

STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-23. The listed applicant is Stethographics, Inc.. The 510(k) number is K012387.

When did STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM receive FDA 510(k) clearance?

STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM received FDA 510(k) clearance on 2002-04-23, under 510(k) number K012387.

Who is the listed applicant for STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM?

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

What is the FDA product code for STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM?

The FDA product code for STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM is BZM.

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 Stethographics, 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.

K052283HEART STG SYSTEM AND SOFTWARE

Related Devices (Code: BZM)

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.

K102229PULMOTRACK 2020 SYSTEMKarmelsonixK090863PERSONAL WHEEZOMETERKarmelsonixK071955WIM-PC, MODEL 1010KarmelsonixK980878PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.K974200ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.K955432CPX, CCM, CATH WITH 15% CO2Medical Graphics Corp.

Official Source

View on FDA Database →

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

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