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510(k) K964697

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION by Advance Medical Device, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1997
Date Received
November 22, 1996
Clearance Type
Traditional
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 Advance Medical Device, Inc.

  • K943200 — FLOSCOPE SUPER VASCULAR LAB (November 21, 1995)
  • K910441 — FLOSCOPE MICRODOP (March 21, 1991)
  • K905157 — FLOSCOPE VASCULAR LAB. (March 15, 1991)
  • K903744 — PHYSICIAN'S CHOICE (September 12, 1990)

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