The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd with the FDA for F&p Sleepstyle.
| Device ID | K173193 |
| 510k Number | K173193 |
| Device Name: | F&P SleepStyle |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place East Tamaki, NZ 2013 |
| Contact | Jayanti Karandikar |
| Correspondent | Jayanti Karandikar Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place East Tamaki, NZ 2013 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012448415 | K173193 | 000 |
| 09420012448347 | K173193 | 000 |
| 09420012448354 | K173193 | 000 |