The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd. with the FDA for Dual Heated Infant Vreathing Cirouits.
| Device ID | K103767 |
| 510k Number | K103767 |
| Device Name: | DUAL HEATED INFANT VREATHING CIROUITS |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | FISHER & PAYKEL HEALTHCARE LTD. 15 MAURICE PAYKEL PLACE PO BOX 14648 Auckland, NZ 1071 |
| Contact | Robert Petry |
| Correspondent | Robert Petry FISHER & PAYKEL HEALTHCARE LTD. 15 MAURICE PAYKEL PLACE PO BOX 14648 Auckland, NZ 1071 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2012-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012424372 | K103767 | 000 |
| 09420012424365 | K103767 | 000 |