510(k) K141362

PULSE OXIMETER CMS50EW by Contec Medical Systems Co.,Ltd — Product Code DQA

K141362 is an FDA 510(k) premarket notification submitted by Contec Medical Systems Co.,Ltd for the device "PULSE OXIMETER CMS50EW". The FDA issued a decision of Substantially Equivalent on April 23, 2015. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Contec Medical Systems Co.,Ltd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2015
Date Received
May 23, 2014
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