Techfil

FDA 510(k) K954801 · Technimeca Medic, Inc.

Substantially Equivalent

510(k) numberK954801

Submission

Device name
Techfil
Applicant
Technimeca Medic, Inc.
St. Laurent, Quebec, CA
Received
October 19, 1995
Decision date
January 25, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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K051666Gav - General Anaesthetic VaporizerCAD · Traditional General Anaesthetic Services Limited08/23/2005SE
K042276D-VaporCAD · Traditional Draeger Medical, Inc.09/23/2004SE
K041076Delta TCAD · Special Penlon , Ltd.08/09/2004SE
K031027Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)CAD · Special Datex-Ohmeda, Inc.06/26/2003SE

More from Datex-Ohmeda, Inc.

510(k)DeviceDecision
K953748TechnofilCAD · Traditional 01/25/1996SE

Questions and answers

When was Techfil cleared by the FDA?

Techfil (K954801) received a 510(k) decision of Substantially Equivalent on January 25, 1996, 98 days after the submission was received.

What is the product code of K954801?

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