The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Disposable Co2 Gas Sampling/oxygen Delivery Cannul.
| Device ID | K915228 |
| 510k Number | K915228 |
| Device Name: | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
| Contact | William J Lacey |
| Correspondent | William J Lacey HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-20 |
| Decision Date | 1992-02-11 |