Cleared Traditional

AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH

K933597 · Arthro-Medic, Inc. · General Hospital
Nov 1993
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K933597 is an FDA 510(k) clearance for the AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCH, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Arthro-Medic, Inc. (Sweden, SE). The FDA issued a Cleared decision on November 1, 1993, 98 days after receiving the submission on July 26, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K933597 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1993
Decision Date November 01, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code BYD — Condenser, Heat And Moisture (artificial Nose)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5375