KONIX ULTRASOUND GEL— 510(k) K101952
Substantially EquivalentTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
FDA 510(k) clearance K101952 for KONIX ULTRASOUND GEL, Substantially Equivalent on 2011-05-27. Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa.
Clearance details
- Applicant
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
- Product code
- Code ITX
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zephyr Cove, NV, US
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.