The following data is part of a premarket notification filed by Zefon Medical Products with the FDA for Zefon Gas Sampling Lines.
| Device ID | K930957 |
| 510k Number | K930957 |
| Device Name: | ZEFON GAS SAMPLING LINES |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
| Contact | Robert Stone |
| Correspondent | Robert Stone ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-23 |
| Decision Date | 1993-07-02 |