510(k) K984142

SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 by Mettler Electronics Corp. — Product Code IPF

K984142 is an FDA 510(k) premarket notification submitted by Mettler Electronics Corp. for the device "SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994". The FDA issued a decision of Substantially Equivalent on February 9, 1999. 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
February 9, 1999
Date Received
November 18, 1998
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