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FDA 510(k)

QUAZAR ESOPHAGEAL STETHOSCOPE

K-Number: K841574 · 1984-08-15

ApplicantAxiom Medical, Inc.
Decision Date1984-08-15
Product CodeBZW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

QUAZAR ESOPHAGEAL STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1984-08-15 under 510(k) number K841574. The device is classified under product code BZW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUAZAR ESOPHAGEAL STETHOSCOPE?

QUAZAR ESOPHAGEAL STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K841574.

When did QUAZAR ESOPHAGEAL STETHOSCOPE receive FDA 510(k) clearance?

QUAZAR ESOPHAGEAL STETHOSCOPE received FDA 510(k) clearance on 1984-08-15, under 510(k) number K841574.

Who is the listed applicant for QUAZAR ESOPHAGEAL STETHOSCOPE?

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

What is the FDA product code for QUAZAR ESOPHAGEAL STETHOSCOPE?

The FDA product code for QUAZAR ESOPHAGEAL STETHOSCOPE is BZW.

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Other records listing Axiom Medical, 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.

K993592AXIOM MULTIPURPOSE WOUND DRAINK971851INTERPLEURAL ANESTHESIA CATHETERK965146FLAT CLOSED WOUND DRAIN WITH TROCARK934895GLASSMAN SILICONE CATHETERK922760ATRAUM WOUND DRESSING--MODIFICATIONK905422PVC ROUND WOUND DRAINS

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Related Devices (Code: BZW)

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.

K874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORMon-A-Therm, Inc.K860558ESOPHAGEAL STETHOSCOPESharn, Inc.K844444ESOPHAGEAL STETHOSCOPEMedical Parameters, Inc.K843070ESOPHAGEAL STETHOSCOPESPrimrose Medical, Inc.K842865ESOPHAGEAL STETHOSCOPEInmed Corp.K830329ESOPHAGEAL STETHOSCOPEScience Development 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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