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510(k) K894968

ULTRACOMPACT by Eutectic Electronics, Inc. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
August 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uroflowmeter
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances by Eutectic Electronics, Inc.

  • K850867 — ACCUTRACKER HEART-RATE MONITOR (May 16, 1985)

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  • K971913 — GR100F URINE FLOWMETER (September 19, 1997)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K951442 — FLOLAB (August 24, 1995)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 1995)
  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)
  • K904557 — MICROFLO (December 28, 1990)
  • K902408 — DIAGNOSTIC ULTRASOUND UFS 1005 (August 10, 1990)