SYSTEMS INTEGRATION MODEL: ENDOALPHA

Endoscopic Central Control Unit

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Systems Integration Model: Endoalpha.

Pre-market Notification Details

Device IDK100345
510k NumberK100345
Device Name:SYSTEMS INTEGRATION MODEL: ENDOALPHA
ClassificationEndoscopic Central Control Unit
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
ContactStacy Kluesner
CorrespondentStacy Kluesner
OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
Product CodeODA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-05
Decision Date2010-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170291593 K100345 000
04953170291517 K100345 000
04953170291494 K100345 000
04953170291470 K100345 000
04953170286117 K100345 000
04953170286049 K100345 000
04953170286032 K100345 000
04953170026386 K100345 000
04953170148040 K100345 000

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