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510(k) K903193

SMITH & NEPHEW DYONICS LEVELERT SYSTEM by Smith & Nephew Dyonics, Inc. — Product Code FLN

K903193 is an FDA 510(k) premarket notification submitted by Smith & Nephew Dyonics, Inc. for the device "SMITH & NEPHEW DYONICS LEVELERT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 30, 1990. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Smith & Nephew Dyonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1990
Date Received
July 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
Submission Type

Other clearances by Smith & Nephew Dyonics, Inc.

  • K955914 — LIMITED REUSE ARTHROSCOPIC BLADES (February 8, 1996)
  • K954627 — ECTRA II LIGAMENT RELEASE SYSTEM (December 18, 1995)
  • K954989 — DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES (November 27, 1995)
  • K953695 — DYONICS DISPOSABLE ARTHROSCOPIC BLADES (September 15, 1995)
  • K953387 — ECTRA LIGAMENT RELEASE SYSTEM (August 9, 1995)
  • K945182 — DYONICS FIXATION SCREWS (January 24, 1995)
  • K936071 — SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE (August 19, 1994)
  • K934299 — DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION (February 14, 1994)
  • K920267 — DYONICS ARTHROSCOPIC KIT (March 23, 1993)
  • K922176 — INTELIJET SUCTION SUPPLY (November 18, 1992)

Other clearances for product code FLN

  • K172242 — DripAssist Plus (May 25, 2018)
  • K150687 — DripAssist (October 13, 2015)
  • K133870 — FLUID LEVEL MONITOR (April 24, 2014)
  • K080704 — LOW FLUID ALARM (April 17, 2008)
  • K050783 — ISSYS DRUG FLOW MONITOR (February 22, 2006)
  • K060123 — LEVELERT II FLUID LEVEL SENSOR (February 14, 2006)
  • K030136 — DRIP ALERT (April 7, 2003)
  • K022248 — STRYKER L3 HYDROLERT (August 6, 2002)
  • K013121 — MT ALERT INFUSION MONITOR (October 15, 2001)
  • K973025 — FLUID CENTURION (4-100-00) (November 20, 1997)

FDA data resources