The following data is part of a premarket notification filed by Spegas Industries, Ltd. with the FDA for Combination Oximeter/carbon Dioxide Gas Analyzer.
| Device ID | K964239 |
| 510k Number | K964239 |
| Device Name: | COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SPEGAS INDUSTRIES, LTD. 70 WALNUT ST. Wellesley, MA 02181 |
| Contact | Yacov Bubis |
| Correspondent | Yacov Bubis SPEGAS INDUSTRIES, LTD. 70 WALNUT ST. Wellesley, MA 02181 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-23 |
| Decision Date | 1997-05-09 |
| Summary: | summary |