The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Nebulizer, Micro (addi-mist).
| Device ID | K760335 |
| 510k Number | K760335 |
| Device Name: | NEBULIZER, MICRO (ADDI-MIST) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRATORY CARE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-29 |
| Decision Date | 1976-08-11 |