The following data is part of a premarket notification filed by Mittler Supply, Inc. with the FDA for Lung Diffusion Mixtures.
| Device ID | K954804 |
| 510k Number | K954804 |
| Device Name: | LUNG DIFFUSION MIXTURES |
| Classification | Gas, Calibration (specified Concentration) |
| Applicant | MITTLER SUPPLY, INC. 3607 SOUTH MAIN ST. South Bend, IN 46614 |
| Contact | David Finney |
| Correspondent | David Finney MITTLER SUPPLY, INC. 3607 SOUTH MAIN ST. South Bend, IN 46614 |
| Product Code | BXK |
| CFR Regulation Number | 868.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-19 |
| Decision Date | 1996-01-25 |