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FDA 510(k)

T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE

K-Number: K894757 · 1989-09-18

ApplicantLouisville Laboratories, Inc.
Decision Date1989-09-18
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-18 under 510(k) number K894757. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE?

T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1989-09-18. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K894757.

When did T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE receive FDA 510(k) clearance?

T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE received FDA 510(k) clearance on 1989-09-18, under 510(k) number K894757.

Who is the listed applicant for T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE?

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

What is the FDA product code for T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE?

The FDA product code for T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE is BZT.

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Other records listing Louisville Laboratories, 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.

K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SETK971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORSK971791VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSIONK971802VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSIONK971797LAPAROSCOPIC BLADDER NECK SUSPENSION KITK971801LAPAROTOMY BLADDER NECK SUSPENSION KIT

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Related Devices (Code: BZT)

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.

K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)Covidien, LLCK193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchDeroyal Industries, Inc.K111050ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FRStarboard Medical, LLCK092716ESOPHAGEAL STETHOSCOPETruer Medical, Inc.K072621ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSORCincinnati Sub-Zero Products, Inc.K062020LIFESOUND ESOPHAGEAL STETHOSCOPENovamed, LLC

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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