Cleared Traditional

BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES

K020538 · Boehringer Laboratories · General Hospital

May 2002

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K020538 is an FDA 510(k) clearance for the BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES, a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II — Special Controls, product code DWL), submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on May 15, 2002, 85 days after receiving the submission on February 19, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5780.

Submission Details

510(k) Number	K020538 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2002
Decision Date	May 15, 2002
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5780