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510(k) K912701

DANTEC MENUET by Dantec Medical, Inc. — Product Code FAP

K912701 is an FDA 510(k) premarket notification submitted by Dantec Medical, Inc. for the device "DANTEC MENUET". The FDA issued a decision of Substantially Equivalent on December 9, 1991. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Dantec Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
June 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Dantec Medical, Inc.

  • K960503 — DANTEC DUET (September 16, 1996)
  • K950314 — DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) (March 25, 1996)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K926363 — MULTI-DOP S (June 19, 1995)
  • K931801 — MULTI-DOP X (June 14, 1995)
  • K930458 — MULTI-DOP L (February 3, 1995)
  • K932059 — NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (October 4, 1994)
  • K934580 — DANTEC 13R45 BAR ELECTRODE (September 26, 1994)
  • K931966 — DANTEC DISPOSABLE CONCENTRIC NEEDLE (March 30, 1994)
  • K931923 — DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) (November 9, 1993)

Other clearances for product code FAP

  • K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE (December 13, 2012)
  • K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (February 19, 1998)
  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (August 27, 1996)
  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
  • K931179 — UROLAB SPECTRUM (November 18, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)

FDA data resources