The following data is part of a premarket notification filed by Twinmed Products, Inc. with the FDA for Rhinotherm Ultra 2.
| Device ID | K894734 |
| 510k Number | K894734 |
| Device Name: | RHINOTHERM ULTRA 2 |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | TWINMED PRODUCTS, INC. 2601 OCEAN PARK BLVD. Santa Monica, CA 90405 |
| Contact | Edward J Frank |
| Correspondent | Edward J Frank TWINMED PRODUCTS, INC. 2601 OCEAN PARK BLVD. Santa Monica, CA 90405 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1990-02-16 |