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510(k) K823775

Device
BORDON GAGE REGULATOR #BG
Applicant
TIMETER INSTRUMENT CORP.
510(k) number
K823775
Product code
CCN  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-14
Date received
1982-12-14
Regulation
868.2300
Classification name
Flowmeter, Nonback-pressure Compensated, Bourdon Gauge
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K920783OXYGEN FLOW CONTROLLERPuritan Bennett Corp.1992-09-18
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
K802037VITAMIN B12 FOLATE RADIOASSAYCorning Medical & Scientific1980-11-21

Legacy Summary#

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FDA Review#

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