SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200

Endoscopic Video Imaging System/component, Gastroenterology-urology

MEDICAL LASER, INC.

The following data is part of a premarket notification filed by Medical Laser, Inc. with the FDA for Series 5000 Endoscope Console Models 5100 And 5200.

Pre-market Notification Details

Device IDK912447
510k NumberK912447
Device Name:SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis,  MN  55447
ContactGregory J Mathison
CorrespondentGregory J Mathison
MEDICAL LASER, INC. 2605 FERNBROOK LN. Minneapolis,  MN  55447
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-03
Decision Date1991-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B06751691000 K912447 000
B06751500020 K912447 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.