The following data is part of a premarket notification filed by Virotherm Laboratory with the FDA for Virotherm Humidifier.
| Device ID | K915603 |
| 510k Number | K915603 |
| Device Name: | VIROTHERM HUMIDIFIER |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | VIROTHERM LABORATORY 13485 OLD OAK WAY Saratoga, CA 95070 -4206 |
| Contact | William Peretti |
| Correspondent | William Peretti VIROTHERM LABORATORY 13485 OLD OAK WAY Saratoga, CA 95070 -4206 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-16 |
| Decision Date | 1992-10-22 |