510(k) K031876

ELECTRO FLO PERCUSSOR, MODEL 5000 by Med Systems — Product Code BYI

K031876 is an FDA 510(k) premarket notification submitted by Med Systems for the device "ELECTRO FLO PERCUSSOR, MODEL 5000". The FDA issued a decision of Substantially Equivalent on November 21, 2003. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Med Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2003
Date Received
June 17, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type