The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Respiratory Humidifer.
| Device ID | K110019 |
| 510k Number | K110019 |
| Device Name: | RESPIRATORY HUMIDIFER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348, PANMURE Auckland, NZ 1741 |
| Contact | Adele Bindon |
| Correspondent | Adele Bindon FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348, PANMURE Auckland, NZ 1741 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2012-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012407245 | K110019 | 000 |
| 09420012407207 | K110019 | 000 |
| 09420012407184 | K110019 | 000 |
| 09420012407290 | K110019 | 000 |
| 09420012407221 | K110019 | 000 |