The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Gas Sampling Nasal Cannula.
| Device ID | K900979 |
| 510k Number | K900979 |
| Device Name: | GAS SAMPLING NASAL CANNULA |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Contact | Rick Hartnett |
| Correspondent | Rick Hartnett GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-03-16 |