The following data is part of a premarket notification filed by Energetic Pulmonary with the FDA for Energetic Hi-hum Aersol Unit.
| Device ID | K831162 |
| 510k Number | K831162 |
| Device Name: | ENERGETIC HI-HUM AERSOL UNIT |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ENERGETIC PULMONARY 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 | 1983-04-11 |
| Decision Date | 1983-05-09 |