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510(k) K863613

Device
NO-FLO I
Applicant
DESIGN TECHNOLOGIES, INC.
510(k) number
K863613
Product code
CCN  
Decision
Substantially Equivalent (SESE)
Decision date
1986-12-15
Date received
1986-09-16
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#

Contact
LOUIS G ACRI
Address
1471 Pinewood St. Rahway NJ US 07065 07065

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
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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