510(k) K940933

9267 SPO2 ATHENA MODULE by S & W Medico Teknik — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
February 28, 1994
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