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FDA 510(k)

THE BLOOM STETHOSCOPE

K-Number: K830796 · 1983-07-19

ApplicantStethophonics, Inc.
Decision Date1983-07-19
Product CodeLDE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE BLOOM STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Stethophonics, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K830796. The device is classified under product code LDE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BLOOM STETHOSCOPE?

THE BLOOM STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Stethophonics, Inc.. The 510(k) number is K830796.

When did THE BLOOM STETHOSCOPE receive FDA 510(k) clearance?

THE BLOOM STETHOSCOPE received FDA 510(k) clearance on 1983-07-19, under 510(k) number K830796.

Who is the listed applicant for THE BLOOM STETHOSCOPE?

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

What is the FDA product code for THE BLOOM STETHOSCOPE?

The FDA product code for THE BLOOM STETHOSCOPE is LDE.

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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Related Devices (Code: LDE)

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.

K945082CYPRESS MEDICAL PRODUCTS STETHOSCOPECypress Medical Products, Ltd.K944337VARIOUS STETHOSCOPESRud Riester GmbH & CO KGK940578MANUAL STETOSCOPEBhs Intl., Inc.K935944PROSCOPES AND ADSCOPESAmerican Diagnostic Corp.K923327STETHOSCOPE COVERAnup Chakraborty Co.K924095TIMEOSCOPE AND FLEXISCOPEStethoscopes of America, Inc.

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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