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510(k) K935981

MLT-2 by Med Labs, Inc. — Product Code ILQ

K935981 is an FDA 510(k) premarket notification submitted by Med Labs, Inc. for the device "MLT-2". The FDA issued a decision of Substantially Equivalent on February 17, 1994. 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
February 17, 1994
Date Received
December 14, 1993
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)
  • K923819 — EEC-1 PACKAGE (November 6, 1992)
  • 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)
  • K925387 — LIBERATOR (March 29, 1993)
  • K925527 — LIGHT TALKER (March 22, 1993)
  • K924014 — SECRETARY (March 4, 1993)
  • K924030 — SCRIBE (March 4, 1993)
  • K924013 — MACAW (March 4, 1993)

FDA data resources