510(k) K020538

BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES by Boehringer Laboratories — Product Code DWL

K020538 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES". The FDA issued a decision of Substantially Equivalent on May 15, 2002. The device falls under product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)), a Class II device regulated under 21 CFR 880.5780. Boehringer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2002
Date Received
February 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type