510(k) K101577

MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES by Beijing Choice Electronic Technololgy Co., Ltd. — Product Code DQA

K101577 is an FDA 510(k) premarket notification submitted by Beijing Choice Electronic Technololgy Co., Ltd. for the device "MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES". The FDA issued a decision of Substantially Equivalent on December 2, 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
December 2, 2010
Date Received
June 7, 2010
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