The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Surgical Patient Warmer, Model Pw820 Jhu.
| Device ID | K022609 |
| 510k Number | K022609 |
| Device Name: | SURGICAL PATIENT WARMER, MODEL PW820 JHU |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Contact | Robert Petry |
| Correspondent | Robert Petry FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-06 |
| Decision Date | 2003-03-06 |
| Summary: | summary |