The following data is part of a premarket notification filed by Meditera Tibbi Malzeme San. Ve Tic. A.s. with the FDA for Altera Gas Sampling Lines.
| Device ID | K192563 |
| 510k Number | K192563 |
| Device Name: | Altera Gas Sampling Lines |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Meditera Tibbi Malzeme San. Ve Tic. A.S. Ibni Melek OSB Mah. TOSBI Yol 4 Sok No: 29 Tire Organize Sanayi Bolgesi, Tire Izmir, TR 35900 |
| Contact | Cenk Kilic Kalkan |
| Correspondent | Paul Dryden Meditera Tibbi Malzeme San. Ve Tic. A.S. % ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, FL 33704 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-01-17 |