510(k) K953434

MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) by Midas Rex Pneumatic Tools, Inc. — Product Code HBB

K953434 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)". The FDA issued a decision of Substantially Equivalent on May 16, 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
May 16, 1996
Date Received
July 21, 1995
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