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510(k) K121108

DOPPLEX ABILITY by Huntleigh Healthcare — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2013
Date Received
April 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type

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