510(k) K861625

SERVO GAS MONITOR 120 by Siemens Elema AB — Product Code CCL

K861625 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SERVO GAS MONITOR 120". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
April 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type