Cleared Traditional

NCA-200

K931608 · Ics Medical Corp. · Ear, Nose, Throat
Jun 1993
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K931608 is an FDA 510(k) clearance for the NCA-200, a Stimulator, Caloric-air (Class I — General Controls, product code KHH), submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on June 22, 1993, 82 days after receiving the submission on April 1, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1800.

Submission Details

510(k) Number K931608 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1993
Decision Date June 22, 1993
Days to Decision 82 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code KHH — Stimulator, Caloric-air
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.1800