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510(k) K132892

TEBCO-W by Bomed, Inc. — Product Code DXG

K132892 is an FDA 510(k) premarket notification submitted by Bomed, Inc. for the device "TEBCO-W". The FDA issued a decision of Substantially Equivalent on August 1, 2014. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2014
Date Received
September 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

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FDA data resources