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

MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T

K Number: K904796 · Decision Nov 26, 1990
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
37
Applicant Total
1
Review Days
34

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Basic Information

Device Name
MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T
K Number
K904796
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.3710
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Personal Emergency Response System
Date Received
October 23, 1990
Decision Date
November 26, 1990
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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