The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Remrest Heated Humidifier.
| Device ID | K050990 |
| 510k Number | K050990 |
| Device Name: | REMREST HEATED HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2636 289TH PLACE Adel, IA 50003 -8021 |
| Contact | Keith Theisen |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-19 |
| Decision Date | 2005-05-02 |
| Summary: | summary |