The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Respiratory Humidifier, Model Mr850.
| Device ID | K073706 |
| 510k Number | K073706 |
| Device Name: | RESPIRATORY HUMIDIFIER, MODEL MR850 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Contact | Adele Bindon |
| Correspondent | Adele Bindon FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012407252 | K073706 | 000 |