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FDA 510(k)

PULMOTRACK,MODEL 1010

K-Number: K980878 · 1998-12-28

ApplicantKarmel Medical Acoustic Technologies , Ltd.
Decision Date1998-12-28
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMOTRACK,MODEL 1010 is the device name listed in this FDA 510(k) record. The listed applicant is Karmel Medical Acoustic Technologies , Ltd.. It received FDA 510(k) clearance on 1998-12-28 under 510(k) number K980878. 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 PULMOTRACK,MODEL 1010?

PULMOTRACK,MODEL 1010 is a medical device that received FDA 510(k) clearance on 1998-12-28. The listed applicant is Karmel Medical Acoustic Technologies , Ltd.. The 510(k) number is K980878.

When did PULMOTRACK,MODEL 1010 receive FDA 510(k) clearance?

PULMOTRACK,MODEL 1010 received FDA 510(k) clearance on 1998-12-28, under 510(k) number K980878.

Who is the listed applicant for PULMOTRACK,MODEL 1010?

The FDA 510(k) record lists Karmel Medical Acoustic Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULMOTRACK,MODEL 1010?

The FDA product code for PULMOTRACK,MODEL 1010 is BZM.

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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 1010KarmelsonixK012387STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMStethographics, Inc.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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