The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Sleepstyle 200 Auto Series Hc254.
| Device ID | K081029 |
| 510k Number | K081029 |
| Device Name: | SLEEPSTYLE 200 AUTO SERIES HC254 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Contact | James Thompson |
| Correspondent | James Thompson FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-11 |
| Decision Date | 2008-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012421524 | K081029 | 000 |
| 09420012421647 | K081029 | 000 |
| 09420012421616 | K081029 | 000 |