The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Cloud 1 Humidification System.
| Device ID | K983862 |
| 510k Number | K983862 |
| Device Name: | CLOUD 1 HUMIDIFICATION SYSTEM |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
| Contact | Gordon Shigezawa |
| Correspondent | Gordon Shigezawa RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-05-24 |
| Summary: | summary |