Cleared Traditional

INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING

K873498 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology

Mar 1988

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K873498 is an FDA 510(k) clearance for the INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING, a Meter, Airway Pressure (inspiratory Force) (Class II — Special Controls, product code BXR), submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on March 9, 1988, 191 days after receiving the submission on August 31, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1780.

Submission Details

510(k) Number	K873498 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1987
Decision Date	March 09, 1988
Days to Decision	191 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—