The following data is part of a premarket notification filed by Adherium (nz) Ltd with the FDA for Hailie Sensor Nf0109.
Device ID | K211233 |
510k Number | K211233 |
Device Name: | Hailie Sensor NF0109 |
Classification | Nebulizer (direct Patient Interface) |
Applicant | Adherium (NZ) Ltd Level 11, 16 Kingston Street Auckland, NZ 1010 |
Contact | Chris Mander |
Correspondent | Chris Mander Adherium (NZ) Ltd Level 11, 16 Kingston Street Auckland, NZ 1010 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-23 |
Decision Date | 2021-08-18 |