Cleared Traditional

K925237 - AUTOMATIC CALORIC IRRIGATION SYSTEM
(FDA 510(k) Clearance)

K925237 · Ics Medical Corp. · Ear, Nose, Throat device

May 1993

Decision

201d

Days

Class 1

Risk

K925237 is an FDA 510(k) clearance for the AUTOMATIC CALORIC IRRIGATION SYSTEM. This device is classified as 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 May 5, 1993, 201 days after receiving the submission on October 16, 1992.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1800.

Submission Details

510(k) Number	K925237 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 16, 1992
Decision Date	May 05, 1993
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement