510(k) K023293

MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 by Med-Tec,Inc. — Product Code IYE

K023293 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02". The FDA issued a decision of Substantially Equivalent on December 23, 2002. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Med-Tec,Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2002
Date Received
October 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type