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510(k) K882817

Device
LUNG DIFFUSION GAS MIXTURE
Applicant
SWISCO, INC.
510(k) number
K882817
Product code
BYK  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-15
Date received
1988-07-08
Regulation
868.5710
Classification name
Tent, Oxygen, Electrically Powered
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEE PHILLIPS
Address
P.O. Box 1563 Lake Charles LA US 70602 70602

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941547CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENTAllied Healthcare Products, Inc.1995-03-01
K813235DISS FEMALE AIR ADAPTORTimeter Instrument Corp.1981-12-08

Legacy Summary#

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FDA Review#

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