510(k) K040932

EASYNET BODY POSITION MODULE by Cadwell Laboratories, Inc. — Product Code LEL

K040932 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "EASYNET BODY POSITION MODULE". The FDA issued a decision of Substantially Equivalent on July 1, 2004. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2004
Date Received
April 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type