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510(k) K944495

MODEL 3200 VASCULAR MINI-LAB by Parks Medical Electronics, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1995
Date Received
September 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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