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510(k) K041778

REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T by Maxi-Aids, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2004
Date Received
July 1, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Maxi-Aids, Inc.

  • K960567 — HF MEGA EAR (October 16, 1996)

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