The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Fisher & Paykel Healthecare Oracle Oral Mask.
| Device ID | K023559 |
| 510k Number | K023559 |
| Device Name: | FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. P.O BOX 14-348 Panmure, Auckland, NZ 1701 |
| Contact | Kevin Sherlock |
| Correspondent | Kevin Sherlock FISHER & PAYKEL HEALTHCARE, LTD. P.O BOX 14-348 Panmure, Auckland, NZ 1701 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-23 |
| Decision Date | 2003-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012411709 | K023559 | 000 |