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510(k) K870039

Device
IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM
Applicant
PAR MICROSYSTEMS CORP.
510(k) number
K870039
Product code
DSF  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-12
Date received
1987-01-05
Regulation
870.2810
Classification name
Recorder, Paper Chart
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES L CAMBIER,PHD
Address
220 Seneca Tpke. New Hartford NY US 13413 13413

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DSF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.1991-08-29
K912929DASH IVAstro-Med, Inc.1991-08-13
K905856MODEL 556 MONITORGe Medical Systems Information Technologies1991-01-11
K902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.1990-06-22
K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.1990-06-19
K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, Inc.1990-05-09
K895111TYPE 9541 RECORDER, PAPER CHARTS & W Medico Teknik1990-01-26
K894922WR3500 AND WR3600 SERIES RECORDERSWestern Graphtec1990-01-26
K894736MT96000 PAPER CHART RECORDERAstro-Med, Inc.1989-12-13
K894607PAQ10 PAPER CHART RECORDERProtocol Systems, Inc.1989-10-26
K893561EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.Edentec Corp.1989-08-25
K885058CARDIOCAP(TM) DR-104 REPORTERDatex Division Instrumentarium Corp.1989-07-14
K890711DUAL GRAPH (TM) RECORDER-MONITORSomatics, Inc.1989-06-02
K884897FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDERMennen Medical, Inc.1989-03-09
K890142A10 ULTRASCOPE RECORDEREms Medical, Inc.1989-02-06

Legacy Summary#

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FDA Review#

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