ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT— 510(k) K914887

Name: FDA 510(k) clearance K914887
Creator: U.S. Food and Drug Administration
Published: 1992-05-08

Substantially Equivalent

Mallinckrodt Medical

FDA 510(k) clearance K914887 for ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT, Substantially Equivalent on 1992-05-08. Applicant: Mallinckrodt Medical. Device class: 2.

Clearance details

Applicant: Mallinckrodt Medical
Product code: Code FRQ
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-30
Decision date: 1992-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Louis, MO, US

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