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FDA 510(k)

ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT

K-Number: K914887 · 1992-05-08

ApplicantMallinckrodt Medical
Decision Date1992-05-08
Product CodeFRQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1992-05-08 under 510(k) number K914887. The device is classified under product code FRQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT?

ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT is a medical device that received FDA 510(k) clearance on 1992-05-08. The listed applicant is Mallinckrodt Medical. The 510(k) number is K914887.

When did ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT receive FDA 510(k) clearance?

ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT received FDA 510(k) clearance on 1992-05-08, under 510(k) number K914887.

Who is the listed applicant for ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT?

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

What is the FDA product code for ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT?

The FDA product code for ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT is FRQ.

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Other records listing Mallinckrodt Medical as applicant

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Related Devices (Code: FRQ)

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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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