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510(k) K101983

CRITICAL CARE ASSESSMENT by Critical Patient Care, Inc. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2010
Date Received
July 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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