Cleared Traditional

K874047 - ASTHMAKIT
(FDA 510(k) Clearance)

K874047 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology

Feb 1988

Decision

147d

Days

Class 2

Risk

K874047 is an FDA 510(k) clearance for the ASTHMAKIT, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on February 29, 1988, 147 days after receiving the submission on October 5, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K874047 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 05, 1987
Decision Date	February 29, 1988
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—