The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Servo-control Wall-mount Cosycot Infant Warmer Model Iw960, Manual Control Wall-mount Cosycot Infant Warmer Model Iw970.
| Device ID | K972885 |
| 510k Number | K972885 |
| Device Name: | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 |
| 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 | 1997-08-05 |
| Decision Date | 1997-10-30 |
| Summary: | summary |