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510(k) K953748

Device
Technofil
Applicant
TECHNIMECA MEDIC, INC.
510(k) number
K953748
Product code
CAD
Decision
Substantially Equivalent (SESE)
Decision date
1996-01-25
Date received
1995-08-11
Regulation
868.5880
Classification name
Vaporizer, Anesthesia, Non-Heated
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JACQUES ROBERGE
Address
2300 Cohen St. Laurent, Quebec CA H4R 2N8 H4R 2N8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CAD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240375V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-10-31
K172702Tec 820, Tec 850Datex-Ohmeda, Inc.2018-01-04
K150167V60 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-06-30
K110608SEVOFLURANE VAPORIZER ADAPTORPiramal Critcal Care, Inc (Formerly Minrad, Inc)2011-07-20
K060331SIGMA ALPHA VAPORIZERPenlon Limited2006-05-10
K053564KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454Penlon Limited2006-03-03
K051666GAV - GENERAL ANAESTHETIC VAPORIZERGeneral Anaesthetic Services Limited2005-08-23
K042276D-VAPORDraeger Medical, Inc.2004-09-23
K041076DELTA TPenlon , Ltd.2004-08-09
K031027DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)Datex-Ohmeda, Inc.2003-06-26
K012924DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZERDatex-Ohmeda, Inc.2002-01-30
K002343SIGMA DELTAPenlon , Ltd.2001-06-08
K002878DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZERDatex-Ohmeda, Inc.2000-09-21
K000275DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIADatex-Ohmeda, Inc.2000-04-12
K990132DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TECDatex-Ohmeda, Inc.1999-01-21