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510(k) K951442

FLOLAB by Synectics Medical, Inc. — Product Code EXY

K951442 is an FDA 510(k) premarket notification submitted by Synectics Medical, Inc. for the device "FLOLAB". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Synectics Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
March 29, 1995
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 Synectics Medical, Inc.

  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K961070 — ESOPHAGEAL MANOMETRY ANALYSIS MODULE (June 11, 1996)
  • K946322 — POLYGRAM SOFTWARE (July 7, 1995)
  • K942445 — SYNERGY II (November 22, 1994)

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)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 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