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510(k) K040958

PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 by Tokyo Boeki Medical System , Ltd. — Product Code JJE

K040958 is an FDA 510(k) premarket notification submitted by Tokyo Boeki Medical System , Ltd. for the device "PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240". The FDA issued a decision of Substantially Equivalent on February 15, 2005. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2005
Date Received
April 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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FDA data resources