KONIX ULTRASOUND GEL

Transducer, Ultrasonic, Diagnostic

TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA

The following data is part of a premarket notification filed by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa with the FDA for Konix Ultrasound Gel.

Pre-market Notification Details

Device IDK101952
510k NumberK101952
Device Name:KONIX ULTRASOUND GEL
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 88 MCFAUL WAY P.O. BOX 10321 Zephyr Cove,  NV  89448
ContactMichael Scott
CorrespondentMichael Scott
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 88 MCFAUL WAY P.O. BOX 10321 Zephyr Cove,  NV  89448
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-12
Decision Date2011-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10818566013658 K101952 000
30193489025297 K101952 000
40080196166252 K101952 000
40080196166290 K101952 000
10810041988567 K101952 000
10035135013059 K101952 000
20818566012801 K101952 000
00818566012814 K101952 000
10818566012828 K101952 000
10818566012835 K101952 000
00818566012845 K101952 000
40080196306238 K101952 000

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