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 |