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FDA 510(k)

MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR

K-Number: K874519 · 1988-01-29

ApplicantMon-A-Therm, Inc.
Decision Date1988-01-29
Product CodeBZW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Mon-A-Therm, Inc.. It received FDA 510(k) clearance on 1988-01-29 under 510(k) number K874519. 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 MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR?

MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 1988-01-29. The listed applicant is Mon-A-Therm, Inc.. The 510(k) number is K874519.

When did MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR receive FDA 510(k) clearance?

MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR received FDA 510(k) clearance on 1988-01-29, under 510(k) number K874519.

Who is the listed applicant for MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR?

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

What is the FDA product code for MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR?

The FDA product code for MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR is BZW.

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Other records listing Mon-A-Therm, 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.

K885187MODEL 1000 ELECTRONIC CLINICAL THERMOMETERK874522MODIFIED MYOCARDIAL TEMPERATURE SENSORK875234MON-A-THERM'S SKIN TEMPERATURE SENSORK874524MODIFIED SUBCUTANEOUS TEMPERATURE SENSORK874523MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSORK874521MODIFIED THERMAL WELL TEMPERATURE SENSOR

View all 17 devices →

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.

K860558ESOPHAGEAL STETHOSCOPESharn, Inc.K844444ESOPHAGEAL STETHOSCOPEMedical Parameters, Inc.K843070ESOPHAGEAL STETHOSCOPESPrimrose Medical, Inc.K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom 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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