The following data is part of a premarket notification filed by Seven Harvest Intl. Import & Export with the FDA for Bubble Humidifiers.
| Device ID | K823143 |
| 510k Number | K823143 |
| Device Name: | BUBBLE HUMIDIFIERS |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SEVEN HARVEST INTL. IMPORT & EXPORT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-25 |
| Decision Date | 1982-11-29 |