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510(k) K914397

Device
OXFORD OPTRONIX MPM 3S
Applicant
DIA-STRON, LTD.
510(k) number
K914397
Product code
FTI  
Decision
Substantially Equivalent (SESE)
Decision date
1992-11-16
Date received
1991-10-01
Regulation
876.1500
Classification name
Lamp, Endoscope, Incandescent
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MR. S RIMDZIUS
Address
835-837 Sussex Blvd. Broomall PA US 19008 19008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FTI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971455CLARUS MODEL 5197 SIGHTLITEClarus Medical Systems, Inc.1997-05-20

Legacy Summary#

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FDA Review#

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