The following data is part of a premarket notification filed by Fisher & Paykel Allied Products Ltd. with the FDA for Dual Servo Heated Respiratory Humidifier.
| Device ID | K822816 |
| 510k Number | K822816 |
| Device Name: | DUAL SERVO HEATED RESPIRATORY HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL ALLIED PRODUCTS LTD. 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 | 1982-09-20 |
| Decision Date | 1982-10-22 |