Esophageal Stethoscope W/Temp Sensor/Gastric Suct

FDA 510(k) K914887 · Mallinckrodt Medical

Substantially Equivalent

510(k) numberK914887

Submission

Device name
Esophageal Stethoscope W/Temp Sensor/Gastric Suct
Applicant
Mallinckrodt Medical
St Louis, MO, US
Received
October 30, 1991
Decision date
May 8, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FRQ – Tube, Levine
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

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Questions and answers

When was Esophageal Stethoscope W/Temp Sensor/Gastric Suct cleared by the FDA?

Esophageal Stethoscope W/Temp Sensor/Gastric Suct (K914887) received a 510(k) decision of Substantially Equivalent on May 8, 1992, 191 days after the submission was received.

What is the product code of K914887?

The FDA product code is FRQ – Tube, Levine, a Class II (moderate risk) device regulated under 21 CFR 876.5980.