The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Resubmitted Rd1000 Neopuff Infant Resuscitator.
| Device ID | K892885 |
| 510k Number | K892885 |
| Device Name: | RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Richard Belgrave |
| Correspondent | Richard Belgrave FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-19 |
| Decision Date | 1989-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012420343 | K892885 | 000 |