FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LIFELINE(R) PERSONAL RESPONSE SYSTEM

K Number: K914103 · Decision Sep 27, 1991
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
37
Applicant Total
4
Review Days
15

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Basic Information

Device Name
LIFELINE(R) PERSONAL RESPONSE SYSTEM
K Number
K914103
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.3710
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Lifeline Systems, Inc.
Date Received
September 12, 1991
Decision Date
September 27, 1991
Product Code
ILQ
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
ILQ System, Communication, Powered

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K Number Device Name
K103214 M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
K834441 BLOOD PRESSURE MONITOR BP600X
K831638 SINGLE BED ARRHYTHMIA MONITOR AM500