510(k) K083229

E.S TECK ( ELECTRO SENSOR TECK) by Ld Technology, LLC — Product Code MWI

K083229 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "E.S TECK ( ELECTRO SENSOR TECK)". The FDA issued a decision of Substantially Equivalent on February 23, 2009. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Ld Technology, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2009
Date Received
November 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type