The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Hc550 Respiratory Humidifier, Adult Ventilator Circuit.
| Device ID | K132017 |
| 510k Number | K132017 |
| Device Name: | HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ 2013 |
| Contact | Elizabeth Goldstein |
| Correspondent | Elizabeth Goldstein FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ 2013 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2014-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012416797 | K132017 | 000 |