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510(k) K914103

LIFELINE(R) PERSONAL RESPONSE SYSTEM by Lifeline Systems, Inc. — Product Code ILQ

K914103 is an FDA 510(k) premarket notification submitted by Lifeline Systems, Inc. for the device "LIFELINE(R) PERSONAL RESPONSE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 1991. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Lifeline Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
September 12, 1991
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 Lifeline Systems, Inc.

  • K103214 — M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 (December 1, 2010)
  • K834441 — BLOOD PRESSURE MONITOR BP600X (May 21, 1984)
  • K831638 — SINGLE BED ARRHYTHMIA MONITOR AM500 (November 14, 1983)

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)
  • K924030 — SCRIBE (March 4, 1993)
  • K924014 — SECRETARY (March 4, 1993)

FDA data resources