Cleared Traditional

FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator

K180863 · Taidoc Technology Corporation · Ear, Nose, Throat
Dec 2018
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K180863 is an FDA 510(k) clearance for the FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 19, 2018, 261 days after receiving the submission on April 2, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K180863 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2018
Decision Date December 19, 2018
Days to Decision 261 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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