The following data is part of a premarket notification filed by Spegas Industries, Ltd. with the FDA for Capnodig.
| Device ID | K933707 |
| 510k Number | K933707 |
| Device Name: | CAPNODIG |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SPEGAS INDUSTRIES, LTD. HAR HOTZVIM INDUSTRIAL PARK P.O.BOX 23650NDUSRIAL PARK Jerusalem, IL 91235 |
| Contact | Sanford Brown |
| Correspondent | Sanford Brown SPEGAS INDUSTRIES, LTD. HAR HOTZVIM INDUSTRIAL PARK P.O.BOX 23650NDUSRIAL PARK Jerusalem, IL 91235 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-30 |
| Decision Date | 1993-10-27 |