FDA.reportPublic FDA data

510(k) K240375

Device
V80 Anesthetic Vaporizer (V80)
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) number
K240375
Product code
CAD
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-31
Date received
2024-02-07
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
Yanhong Bai
Address
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Na Shenzhen CN 518057 518057

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
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
K980489VAPAMASTA 6Medical Industrial Equipment1998-08-31