The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Inspiron Nebulo Basic External Heater.
| Device ID | K880304 |
| 510k Number | K880304 |
| Device Name: | INSPIRON NEBULO BASIC EXTERNAL HEATER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INTERTECH RESOURCES, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Contact | Sheryl Marcouiller |
| Correspondent | Sheryl Marcouiller INTERTECH RESOURCES, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-03-04 |