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510(k) K944972

URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY by Myo/Kinetic Systems, Inc. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1995
Date Received
October 11, 1994
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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  • K936041 — UROGRAM CYSTOMETROGRAM (April 18, 1994)
  • K932611 — NEUROMUSCULAR STIMULATOR (January 31, 1994)
  • K932764 — THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) (October 1, 1993)
  • K932399 — THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) (August 11, 1993)
  • K914904 — THERAPEUTIC STIMULATOR 2100 (TS-2100) (April 28, 1992)

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  • K900770 — HOME URODATA SYSTEM(TM) (June 8, 1990)