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510(k) K900494

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM by Synectics-Dantec — Product Code FAP

K900494 is an FDA 510(k) premarket notification submitted by Synectics-Dantec for the device "SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM". The FDA issued a decision of Substantially Equivalent on June 11, 1990. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Synectics-Dantec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1990
Date Received
February 2, 1990
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 Synectics-Dantec

  • K961346 — PH ANALYSIS MODULE (January 29, 1997)
  • K925405 — ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (September 30, 1994)
  • K924875 — MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS (June 30, 1994)
  • K914793 — MONOCRYSTANT PH/LES CATHETER, MODIFICATION (December 13, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K913817 — MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (June 11, 1992)
  • K914624 — PH METER, MODIFICATION (April 28, 1992)
  • K914219 — AIRWAY THERMISTOR (February 26, 1992)
  • K913387 — DIGITRAPPER MARK III (December 27, 1991)
  • K904625 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM (August 20, 1991)

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