The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Patient Warmer- Model Pw810.
| Device ID | K982636 |
| 510k Number | K982636 |
| Device Name: | PATIENT WARMER- MODEL PW810 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-29 |
| Decision Date | 1998-10-26 |
| Summary: | summary |