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510(k) K040684

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 by Spectros Corporation — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2004
Date Received
March 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation
Device Class
Class II
Regulation Number
870.2700
Review Panel
SU
Submission Type

Other clearances by Spectros Corporation

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