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510(k) K920783

Device
OXYGEN FLOW CONTROLLER
Applicant
PURITAN BENNETT CORP.
510(k) number
K920783
Product code
CCN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-18
Date received
1992-02-20
Regulation
868.2300
Classification name
Flowmeter, Nonback-pressure Compensated, Bourdon Gauge
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARSHALL SMITH
Address
9401 Indian Creek Pkwy. P.O. Box 25905 Overland Park KS US 66225 66225

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934945FLOWMETER NIPPLE ADAPTORCardio-Search , Ltd.1993-11-17
K872038NEB-U-VENTDesign Technologies, Inc.1987-08-10
K871262MODIFIED NOFLO IDesign Technologies, Inc.1987-07-21
K863613NO-FLO IDesign Technologies, Inc.1986-12-15
K863657OXYGEN CONSERVATORSalter Labs1986-10-15
K863659FLOW INTERRUPTION INDICATORSalter Labs1986-10-15
K823775BORDON GAGE REGULATOR #BGTimeter Instrument Corp.1983-01-14
K802037VITAMIN B12 FOLATE RADIOASSAYCorning Medical & Scientific1980-11-21

Legacy Summary#

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FDA Review#

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