The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Aquapak Prefilled Humidifier.
| Device ID | K780562 |
| 510k Number | K780562 |
| Device Name: | AQUAPAK PREFILLED HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | RESPIRATORY CARE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-07 |
| Decision Date | 1978-04-27 |