510(k) K023083

SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 by Mettler Electronics Corp. — Product Code FRN

K023083 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800". The FDA issued a decision of ST on February 28, 2003. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
February 28, 2003
Date Received
September 17, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type