The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd with the FDA for Mr810 System, 900mr810 Adult Single Limb Circuit, 900mr810e Adult Dual Limb Circuit.
| Device ID | K143646 |
| 510k Number | K143646 |
| Device Name: | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Contact | Elizabeth Goldstein |
| Correspondent | Elizabeth Goldstein Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-03-05 |
| Summary: | summary |