The following data is part of a premarket notification filed by Fisher & Paykel Healthcare with the FDA for Airspiral Heated Breathing Tube.
| Device ID | K162553 |
| 510k Number | K162553 |
| Device Name: | AirSpiral Heated Breathing Tube |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | FISHER & PAYKEL HEALTHCARE 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland, NZ 2013 |
| Contact | Stephanie Elvin |
| Correspondent | Brett Whiston FISHER & PAYKEL HEALTHCARE 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland, NZ 2013 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-13 |
| Decision Date | 2018-12-20 |
| Summary: | summary |