510(k) K913489

SIEMENS MICRO2 PULSE OXIMETER by Siemens Medical Electronics — Product Code DQA

K913489 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS MICRO2 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on October 30, 1991. 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
October 30, 1991
Date Received
August 6, 1991
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