The following data is part of a premarket notification filed by Swisco, Inc. with the FDA for Blood Gas Mixture.
| Device ID | K882941 |
| 510k Number | K882941 |
| Device Name: | BLOOD GAS MIXTURE |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | SWISCO, INC. P.O. BOX 1563 Lake Charles, LA 70602 |
| Contact | Lee Phillips |
| Correspondent | Lee Phillips SWISCO, INC. P.O. BOX 1563 Lake Charles, LA 70602 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-07 |
| Decision Date | 1988-09-09 |