Cleared Traditional

AUTOMATIC CALORIC IRRIGATION SYSTEM

K881630 · Ics Medical Corp. · Ear, Nose, Throat
Jun 1988
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K881630 is an FDA 510(k) clearance for the AUTOMATIC CALORIC IRRIGATION SYSTEM, 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 21, 1988, 68 days after receiving the submission on April 14, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1800.

Submission Details

510(k) Number K881630 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1988
Decision Date June 21, 1988
Days to Decision 68 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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