The following data is part of a premarket notification filed by Gulf States Airgas with the FDA for Lung Diffusion Gas Mixture.
| Device ID | K924796 |
| 510k Number | K924796 |
| Device Name: | LUNG DIFFUSION GAS MIXTURE |
| Classification | Gas, Calibration (specified Concentration) |
| Applicant | GULF STATES AIRGAS 5480 HAMILTON BLVD., P.O. BOX 190969 Theodore, AL 36582 |
| Contact | Wade Holt |
| Correspondent | Wade Holt GULF STATES AIRGAS 5480 HAMILTON BLVD., P.O. BOX 190969 Theodore, AL 36582 |
| Product Code | BXK |
| CFR Regulation Number | 868.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-23 |
| Decision Date | 1992-12-17 |