The following data is part of a premarket notification filed by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa with the FDA for Konix Ultrasound Gel.
| Device ID | K101952 |
| 510k Number | K101952 |
| Device Name: | KONIX ULTRASOUND GEL |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 88 MCFAUL WAY P.O. BOX 10321 Zephyr Cove, NV 89448 |
| Contact | Michael Scott |
| Correspondent | Michael Scott TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 88 MCFAUL WAY P.O. BOX 10321 Zephyr Cove, NV 89448 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2011-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 |