JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE

Arthroscope

JOIMAX GMBH

The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Joimax Endoscope/multiscope, Thessys Foraminoscope/multiscope, Thessys Laminoscope/multiscope.

Pre-market Notification Details

Device IDK051827
510k NumberK051827
Device Name:JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE
ClassificationArthroscope
Applicant JOIMAX GMBH 718 UNIVERSITY AVE., SUITE 116 Los Gatos,  CA  95032
ContactKarin Gastineau
CorrespondentMorten Simon Christensen
UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara,  CA  95050
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-07-06
Decision Date2005-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04250337118473 K051827 000
04250337100430 K051827 000
04250337100447 K051827 000
04250337100454 K051827 000
04250337100485 K051827 000
04250337100492 K051827 000
04250337105756 K051827 000
04250337105763 K051827 000
04250337105770 K051827 000
04250337100423 K051827 000
04250337100041 K051827 000
04250337118480 K051827 000
04250337117650 K051827 000
04250337118404 K051827 000
04250337118411 K051827 000
04250337100003 K051827 000
04250337100010 K051827 000
04250337100027 K051827 000
04250337100034 K051827 000
04250337105787 K051827 000
04250337105794 K051827 000
04250337105800 K051827 000
04250337111252 K051827 000
04250337114321 K051827 000
04250337114680 K051827 000
04250337114697 K051827 000
04250337116011 K051827 000
04250337116028 K051827 000
04250337116318 K051827 000
04250337116325 K051827 000
04250337111245 K051827 000
04250337111238 K051827 000
04250337105879 K051827 000
04250337109600 K051827 000
04250337109617 K051827 000
04250337109662 K051827 000
04250337109679 K051827 000
04250337110576 K051827 000
04250337110583 K051827 000
04250337111221 K051827 000
04250337117643 K051827 000

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