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510(k) K912333

Device
ARTEMA AQUA+
Applicant
ARTEMA MEDICAL AB
510(k) number
K912333
Product code
BYD  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-26
Date received
1991-05-24
Regulation
868.5375
Classification name
Condenser, Heat And Moisture (artificial Nose)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CARL HAMILTON
Address
Rissneleden 136 S-172 48 Sundyberg Sweden SE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.1996-01-30
K954194DISPOSABLE HME/FILTEREngstrom Medical1995-10-20
K953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.1995-09-15
K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor AB1995-09-07
K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.1995-08-25
K953619WARM N WET HME W/LUER ADAPTERHospitak, Inc.1995-08-25
K953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.1995-08-25
K953540EEEEdentec Corp.1995-08-25
K953491HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLEGibeck, Inc.1995-08-25
K952845HUMID-VENT TRACH-VENTGibeck, Inc.1995-07-25
K952750HUMID-VENT 1Gibeck, Inc.1995-07-20
K952844HUMID-VENT 2Gibeck, Inc.1995-07-20
K952823FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBEIcor AB1995-07-13
K952084HUMID-VENT FILTER PEDIGibeck, Inc.1995-06-12
K946209DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HMEMed-Plastics Intl., Inc.1995-06-08

Legacy Summary#

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FDA Review#

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