510(k) K871293

SERVO NEBULIZER 945 SIEMENS-ELEMA AB by Siemens Elema AB — Product Code CAF

K871293 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SERVO NEBULIZER 945 SIEMENS-ELEMA AB". The FDA issued a decision of Substantially Equivalent on May 8, 1987. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type