Cleared Traditional

CRITICAL MEASUREMENT UNIT

K822556 · Bemis Health Care · General Hospital
Oct 1982
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K822556 is an FDA 510(k) clearance for the CRITICAL MEASUREMENT UNIT, a Trap, Sterile Specimen (Class II — Special Controls, product code BYZ), submitted by Bemis Health Care (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982, 55 days after receiving the submission on August 24, 1982. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K822556 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1982
Decision Date October 18, 1982
Days to Decision 55 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