The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Infant Radiant Warmer - Models Iw910 And Iw920.
| Device ID | K970432 |
| 510k Number | K970432 |
| Device Name: | INFANT RADIANT WARMER - MODELS IW910 AND IW920 |
| Classification | Warmer, Infant Radiant |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. HEALTHCARE DIV. 25 CARBINE RD., P.O. BOX 14348 Auckland, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL ELECTRONICS LTD. HEALTHCARE DIV. 25 CARBINE RD., P.O. BOX 14348 Auckland, NZ |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-04 |
| Decision Date | 1997-05-07 |
| Summary: | summary |