510(k) K940933

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

K940933 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "9267 SPO2 ATHENA MODULE". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. S & W Medico Teknik has at least 10 other 510(k) clearances on record.

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