The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Variable Nebulizer Heater.
| Device ID | K851074 |
| 510k Number | K851074 |
| Device Name: | VARIABLE NEBULIZER HEATER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Brian Stembal |
| Correspondent | Brian Stembal TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-06-18 |