The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Rt 138 & Rt 141 Dual-heated Neonatal Breathing Circuits.
| Device ID | K034026 |
| 510k Number | K034026 |
| Device Name: | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE Auckland, NZ 1701 |
| Contact | Adele Bindon |
| Correspondent | Adele Bindon FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE Auckland, NZ 1701 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2005-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012413253 | K034026 | 000 |
| 09420012412966 | K034026 | 000 |