Cleared Traditional

ONE-WAY AIR VALVE

K840253 · Delta Medical Industries · General Hospital
Apr 1984
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K840253 is an FDA 510(k) clearance for the ONE-WAY AIR VALVE, a Trap, Sterile Specimen (Class II — Special Controls, product code BYZ), submitted by Delta Medical Industries (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984, 73 days after receiving the submission on January 23, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K840253 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1984
Decision Date April 05, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code BYZ — Trap, Sterile Specimen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740