The following data is part of a premarket notification filed by Feellife Health Inc. with the FDA for Portable Mesh Nebulizer.
Device ID | K182906 |
510k Number | K182906 |
Device Name: | Portable Mesh Nebulizer |
Classification | Nebulizer (direct Patient Interface) |
Applicant | FeelLife Health Inc. Room 1903, Building A, No.9 Furong Road, Tantou Bao'an District Shenzhen, CN 518104 |
Contact | Owen Zhang |
Correspondent | Jonathan Hu Medwheat (Shanghai) Medical Technology Co. Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai, CN 200082 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-17 |
Decision Date | 2020-09-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06934325388540 | K182906 | 000 |
06934325302249 | K182906 | 000 |
06934325302263 | K182906 | 000 |
06934325301846 | K182906 | 000 |
06934325319490 | K182906 | 000 |
06934325322278 | K182906 | 000 |
06934325338705 | K182906 | 000 |
06934325349237 | K182906 | 000 |
06934325358475 | K182906 | 000 |
06934325371733 | K182906 | 000 |
06934325376950 | K182906 | 000 |
06934325380353 | K182906 | 000 |
00848530099497 | K182906 | 000 |