Cleared Traditional

K894138 - MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
(FDA 510(k) Clearance)

K894138 · Medipart Jerry Alexander · Anesthesiology

Sep 1989

Decision

105d

Days

Class 2

Risk

K894138 is an FDA 510(k) clearance for the MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on September 26, 1989, 105 days after receiving the submission on June 13, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K894138 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 1989
Decision Date	September 26, 1989
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—