The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Ltd. with the FDA for F&p Evora Nasal Mask Nasal A Model (small, Medium, Large, Wide), F&p Evora Nasal Mask Nasal Fit Pack/ Sml (small/medium/large) A Model, F&p Evora Nasal Mask Nasal Sleep Lab (small, Medium, Large, Wide), F&p Evora Nasal Mask Nasal Fit Pack / Sml (smal.
Device ID | K200089 |
510k Number | K200089 |
Device Name: | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Smal |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | Fisher & Paykel Healthcare Ltd. 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
Contact | Reena Daken |
Correspondent | Reena Daken Fisher & Paykel Healthcare Ltd. 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-01-15 |
Decision Date | 2020-06-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09420012460103 | K200089 | 000 |
09420012460097 | K200089 | 000 |
09420012460080 | K200089 | 000 |
09420012460073 | K200089 | 000 |
09420012459930 | K200089 | 000 |
09420012459923 | K200089 | 000 |
09420012459916 | K200089 | 000 |
09420012459909 | K200089 | 000 |
09420012459893 | K200089 | 000 |