Cleared Traditional

THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT

K962749 · Diemolding Corp. · Anesthesiology

Oct 1996

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K962749 is an FDA 510(k) clearance for the THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on October 10, 1996, 87 days after receiving the submission on July 15, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number	K962749 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 1996
Decision Date	October 10, 1996
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF