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510(k) K073593

I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 by Deltex Medical Limited — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2009
Date Received
December 21, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

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