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510(k) K923561

AC-901 I.V. INFUSION DROP COUNTER by Lamtic, Inc. — Product Code FLN

K923561 is an FDA 510(k) premarket notification submitted by Lamtic, Inc. for the device "AC-901 I.V. INFUSION DROP COUNTER". The FDA issued a decision of Substantially Equivalent on May 26, 1993. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Lamtic, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1993
Date Received
July 17, 1992
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 Lamtic, Inc.

  • K923560 — ACCU-DROP I.V. EXTENSION SET (June 17, 1993)

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