The following data is part of a premarket notification filed by Medical Technical Gases Inc.. with the FDA for Med-tech Lung Diffusion Mixture.
| Device ID | K953934 |
| 510k Number | K953934 |
| Device Name: | MED-TECH LUNG DIFFUSION MIXTURE |
| Classification | Gas, Calibration (specified Concentration) |
| Applicant | MEDICAL TECHNICAL GASES INC.. 20 HALL ST. Medford, MA 02155 |
| Contact | Ramesh V Kapur |
| Correspondent | Ramesh V Kapur MEDICAL TECHNICAL GASES INC.. 20 HALL ST. Medford, MA 02155 |
| Product Code | BXK |
| CFR Regulation Number | 868.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1995-09-18 |