510(k) K893470

SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE by Siemens Medical Electronics — Product Code DQA

K893470 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
May 4, 1989
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