510(k) K061706

CADWELL EASYNET OXIMETER MODULE by Cadwell Laboratories, Inc. — Product Code DQA

K061706 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "CADWELL EASYNET OXIMETER MODULE". The FDA issued a decision of Substantially Equivalent on March 5, 2007. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2007
Date Received
June 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type