510(k) K180863

FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator by Taidoc Technology Corporation — Product Code BTA

K180863 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator". The FDA issued a decision of Substantially Equivalent on December 19, 2018. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2018
Date Received
April 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type