Technofil

FDA 510(k) K953748 · Technimeca Medic, Inc.

Substantially Equivalent

510(k) numberK953748

Submission

Device name
Technofil
Applicant
Technimeca Medic, Inc.
St. Laurent, Quebec, CA
Received
August 11, 1995
Decision date
January 25, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAD – Vaporizer, Anesthesia, Non-Heated
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5880
Specialty
Anesthesiology

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More from Datex-Ohmeda, Inc.

510(k)DeviceDecision
K954801TechfilCAD · Traditional 01/25/1996SE

Questions and answers

When was Technofil cleared by the FDA?

Technofil (K953748) received a 510(k) decision of Substantially Equivalent on January 25, 1996, 167 days after the submission was received.

What is the product code of K953748?

The FDA product code is CAD – Vaporizer, Anesthesia, Non-Heated, a Class II (moderate risk) device regulated under 21 CFR 868.5880.