510(k) K923418

9293/1 INTERFACE MODULE by S & W Medico Teknik — Product Code DQA

K923418 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "9293/1 INTERFACE MODULE". The FDA issued a decision of Substantially Equivalent on February 23, 1993. 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
February 23, 1993
Date Received
July 13, 1992
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