The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Servo-control Cosycot Infant Warmer, Manual-control Cosycot Infant Warmer.
| Device ID | K971695 |
| 510k Number | K971695 |
| Device Name: | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE RD. Auckland, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE RD. 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 | 1997-05-08 |
| Decision Date | 1997-07-28 |
| Summary: | summary |