Home / 510(k) Clearances / K944972

510(k) K944972

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

K944972 is an FDA 510(k) premarket notification submitted by Myo/Kinetic Systems, Inc. for the device "URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY". The FDA issued a decision of Substantially Equivalent on March 8, 1995. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Myo/Kinetic Systems, Inc. has at least 7 other 510(k) clearances on record.

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

Other clearances by Myo/Kinetic Systems, Inc.

  • K945937 — TE-800 PELVIC FLOOR EXERCISER (July 14, 1995)
  • K945292 — TS-700P CONTROL XP ELECTRICAL STIMULATOR (April 12, 1995)
  • 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)

Other clearances for product code EXY

  • K142425 — Uroflowmeter (October 27, 2014)
  • K022721 — UROPOWER (August 26, 2003)
  • K971913 — GR100F URINE FLOWMETER (September 19, 1997)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K951442 — FLOLAB (August 24, 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)
  • K900770 — HOME URODATA SYSTEM(TM) (June 8, 1990)

FDA data resources