The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Model Tm101 Temperature Monitor.
| Device ID | K902386 |
| 510k Number | K902386 |
| Device Name: | MODEL TM101 TEMPERATURE MONITOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Richard Belgrave |
| Correspondent | Richard Belgrave FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1992-01-28 |