510(k) K962483

MIDAS REX III MOTOR by Midas Rex Pneumatic Tools, Inc. — Product Code HBB

K962483 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "MIDAS REX III MOTOR". The FDA issued a decision of Substantially Equivalent on November 19, 1996. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Midas Rex Pneumatic Tools, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1996
Date Received
June 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type