BYLClass I

Tent, Oxygen

Anesthesiology · 21 CFR 868.5700

MDR events1All time

Recalls1All time

Registered firms11Currently listed

510(k) clearances11All time

Recent MDR events

1 adverse event reports on file

ALLIED HEALTHCARE PRODUCTS, INC.Feb 28, 1997
MalfunctionAllied Healthcare Products, Inc.77904

Event type breakdown

Malfunction1

Most-reported manufacturers

Allied Healthcare Products, Inc.1

Recalls

1 recall events for this product code

Convatec Inc.
TerminatedFeb 15, 2011
Face Tent
Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate.
Z-1255-2011 · View FDA record ↗

Registered firms

11 firms currently registered for this product code

510(k) clearances

11 clearances for this product code