510(k) K092652

FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA by Beijing Choice Electronic Technololgy Co., Ltd. — Product Code DQA

K092652 is an FDA 510(k) premarket notification submitted by Beijing Choice Electronic Technololgy Co., Ltd. for the device "FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA". The FDA issued a decision of Substantially Equivalent on January 8, 2010. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Beijing Choice Electronic Technololgy Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2010
Date Received
August 28, 2009
Clearance Type
Special
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