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510(k) K923819

EEC-1 PACKAGE by Med Labs, Inc. — Product Code ILQ

K923819 is an FDA 510(k) premarket notification submitted by Med Labs, Inc. for the device "EEC-1 PACKAGE". The FDA issued a decision of Substantially Equivalent on November 6, 1992. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Med Labs, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1992
Date Received
July 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type

Other clearances by Med Labs, Inc.

  • K960457 — ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C (September 6, 1996)
  • K935981 — MLT-2 (February 17, 1994)
  • K903652 — SCAN COM AND SCAN COM P (TENTATIVE) (August 24, 1990)

Other clearances for product code ILQ

  • K162817 — Noddle(TM) (January 18, 2017)
  • K943035 — P.A.T. SYSTEM (October 4, 1994)
  • K930044 — COMFORT KEYBOARD SYSTEM (July 14, 1994)
  • K931855 — LIGHTWRITER (May 10, 1994)
  • K935244 — R & D BATTERIES, INC. PART NUMBER 5113 (April 19, 1994)
  • K935981 — MLT-2 (February 17, 1994)
  • K925387 — LIBERATOR (March 29, 1993)
  • K925527 — LIGHT TALKER (March 22, 1993)
  • K924014 — SECRETARY (March 4, 1993)
  • K924030 — SCRIBE (March 4, 1993)

FDA data resources