The following data is part of a premarket notification filed by Gardner Cryogenics with the FDA for Pft Gases.
| Device ID | K781523 |
| 510k Number | K781523 |
| Device Name: | PFT GASES |
| Classification | Flowmeter, Calibration, Gas |
| Applicant | GARDNER CRYOGENICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXY |
| CFR Regulation Number | 868.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-05 |
| Decision Date | 1978-12-01 |