The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Nas100 Electronic Nasal Aspirator, Electronic Nasal Aspirator.
Device ID | K180863 |
510k Number | K180863 |
Device Name: | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
Contact | Sylvia Liu |
Correspondent | Sylvia Liu TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-02 |
Decision Date | 2018-12-19 |
Summary: | summary |