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510(k) K943200

FLOSCOPE SUPER VASCULAR LAB by Advance Medical Device, Inc. — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1995
Date Received
July 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances by Advance Medical Device, Inc.

  • K964697 — AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION (February 11, 1997)
  • K910441 — FLOSCOPE MICRODOP (March 21, 1991)
  • K905157 — FLOSCOPE VASCULAR LAB. (March 15, 1991)
  • K903744 — PHYSICIAN'S CHOICE (September 12, 1990)

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  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)