The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Mr810respiratory Humidifier, 900mr810 Adult Single Limb Circuit, 900mr810e Adult Dual Limb Circuit.
| Device ID | K131957 |
| 510k Number | K131957 |
| Device Name: | MR810RESPIRATORY HUMIDIFIER, 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 Ackland, NZ 2013 |
| Contact | Elizabeth Goldstein |
| Correspondent | Elizabeth Goldstein FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE EAST TAMAKI Ackland, 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 | 2013-06-27 |
| Decision Date | 2013-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012425409 | K131957 | 000 |
| 09420012425423 | K131957 | 000 |
| 09420012411884 | K131957 | 000 |
| 09420012411815 | K131957 | 000 |