510(k) K852772

GAS EVACUATION ACCESSORY by Siemens Elema AB — Product Code CBN

K852772 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "GAS EVACUATION ACCESSORY". The FDA issued a decision of Substantially Equivalent on October 10, 1985. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1985
Date Received
June 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type