The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Adult Evaqua 2' Dual Heated Breathing Circuits.
| Device ID | K122432 |
| 510k Number | K122432 |
| Device Name: | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ 2013 |
| Contact | Robert Petry |
| Correspondent | Robert Petry FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, 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 | 2012-08-10 |
| Decision Date | 2012-12-06 |
| Summary: | summary |