510(k) K073454

FINGERTIP PULSE OXIMETER, MODEL CMS-50C by Contec Medical System Co., Ltd. — Product Code DQA

K073454 is an FDA 510(k) premarket notification submitted by Contec Medical System Co., Ltd. for the device "FINGERTIP PULSE OXIMETER, MODEL CMS-50C". The FDA issued a decision of Substantially Equivalent on May 5, 2008. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Contec Medical System Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2008
Date Received
December 10, 2007
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