510(k) K102442

E.S.O. (ELECTRO SENSOR OXI) by Ld Technology, LLC — Product Code DQA

K102442 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "E.S.O. (ELECTRO SENSOR OXI)". The FDA issued a decision of Substantially Equivalent on September 10, 2010. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Ld Technology, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2010
Date Received
August 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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