ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)

Arthroscope

CONMED LINVATEC

The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Zen Wireless Footswitch (w1000), Zen Wireless Footswitch Adapter (w1100).

Pre-market Notification Details

Device IDK083161
510k NumberK083161
Device Name:ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
ClassificationArthroscope
Applicant CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo,  FL  33773 -4908
ContactSue Dauterman
CorrespondentSue Dauterman
CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo,  FL  33773 -4908
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-27
Decision Date2009-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10845854850770 K083161 000
10845854850312 K083161 000
10845854050316 K083161 000
10845854050934 K083161 000
10845854050941 K083161 000

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