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510(k) K872077

MODEL 1858 CAVRO/PRESSURE MODULE by Life-Tech Intl., Inc. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1987
Date Received
May 29, 1987
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

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  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)
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  • K902408 — DIAGNOSTIC ULTRASOUND UFS 1005 (August 10, 1990)