The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Sterile Water For Inhalation Usp 2d0799.
| Device ID | K851940 |
| 510k Number | K851940 |
| Device Name: | STERILE WATER FOR INHALATION USP 2D0799 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Dennis A Ocwieja |
| Correspondent | Dennis A Ocwieja TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-03 |
| Decision Date | 1985-06-20 |