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FDA 510(k)

MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER

K-Number: K823126 · 1982-11-16

ApplicantElectromedics, Inc.
Decision Date1982-11-16
Product CodeBZW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K823126. 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 MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER?

MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Electromedics, Inc.. The 510(k) number is K823126.

When did MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER receive FDA 510(k) clearance?

MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER received FDA 510(k) clearance on 1982-11-16, under 510(k) number K823126.

Who is the listed applicant for MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER?

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

What is the FDA product code for MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER?

The FDA product code for MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER is BZW.

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Other records listing Electromedics, 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.

K934964ELECTROMEDICS TYMPANIC TEMPERATURE SENSORK933832ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSORK934355ELECTROMEDICS BLOOD HEAT EXCHANGERK930154EL2-SERIES BLOOD COLLECTION REERVOIRK926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIRK925412ELECTROMEDICS TISSUE TRAP/ #TT280

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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.K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom Medical, Inc.

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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