510(k) K101952

KONIX ULTRASOUND GEL by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa — Product Code ITX

K101952 is an FDA 510(k) premarket notification submitted by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa for the device "KONIX ULTRASOUND GEL". The FDA issued a decision of Substantially Equivalent on May 27, 2011. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa has at least 2 other 510(k) clearances on record.