510(k) K905775

SIEMENS ETCO2 CARTRIDGE by Siemens Medical Electronics — Product Code CCK

K905775 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS ETCO2 CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 11, 1991. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1991
Date Received
December 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type