510(k) K893878

SYS*STIM 206A by Mettler Electronics Corp. — Product Code IPF

K893878 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SYS*STIM 206A". The FDA issued a decision of Substantially Equivalent on December 19, 1989. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Mettler Electronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1989
Date Received
May 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type