Cleared Traditional

RINOFLOW MICRONIZED E.N.T. WASH SYSTEM

K973875 · Respironics, Inc. · Ear, Nose, Throat

Jan 1998

Decision

108d

Days

Class 1

Risk

About This 510(k) Submission

K973875 is an FDA 510(k) clearance for the RINOFLOW MICRONIZED E.N.T. WASH SYSTEM, a Irrigator, Powered Nasal (Class I — General Controls, product code KMA), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 26, 1998, 108 days after receiving the submission on October 10, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5550.

Submission Details

510(k) Number	K973875 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 1997
Decision Date	January 26, 1998
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF