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510(k) K904796

MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T by Personal Emergency Response System — Product Code ILQ

K904796 is an FDA 510(k) premarket notification submitted by Personal Emergency Response System for the device "MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T". The FDA issued a decision of Substantially Equivalent on November 26, 1990. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1990
Date Received
October 23, 1990
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 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