The following data is part of a premarket notification filed by Linde Div. Union Carbide Corp. with the FDA for Mediblend (tm) Lung Diffusion Gas Mixtures.
| Device ID | K882210 |
| 510k Number | K882210 |
| Device Name: | MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES |
| Classification | Gas, Calibration (specified Concentration) |
| Applicant | LINDE DIV. UNION CARBIDE CORP. P.O. BOX 6744, 200 COTTONTAIL LANE Somerset, NJ 08875 -6744 |
| Contact | Suzanne G Fiorino |
| Correspondent | Suzanne G Fiorino LINDE DIV. UNION CARBIDE CORP. P.O. BOX 6744, 200 COTTONTAIL LANE Somerset, NJ 08875 -6744 |
| Product Code | BXK |
| CFR Regulation Number | 868.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1988-06-21 |