510(k) K980884

SIEMENS SEVOFLURANE VAPORIZER SV 953 by Siemens Medical Solutions USA, Inc. — Product Code CAD

K980884 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIEMENS SEVOFLURANE VAPORIZER SV 953". The FDA issued a decision of Substantially Equivalent on August 19, 1998. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1998
Date Received
March 9, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaporizer, Anesthesia, Non-Heated
Device Class
Class II
Regulation Number
868.5880
Review Panel
AN
Submission Type