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510(k) K890596

Device
MED-A-CALL ASSIST DEVICE
Applicant
SILENT CALL CORP.
510(k) number
K890596
Product code
IQA  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-14
Date received
1989-01-27
Regulation
890.3725
Classification name
System, Environmental Control, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEORGE J ELWELL
Address
P.O. Box 16348 Clarkston MI US 48016 48016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IQA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961306DELTATALKER WITH INFRAREDPrentke Romich Co.1996-06-27
K953905IMPERIUMTeledyne Brown Engineering1995-11-21
K953937LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEMApt Technology, Inc.1995-10-31
K943244DEUCEApt Technology, Inc.1995-09-11
K944585SCANNING DIRECTORPrentke Romich Co.1995-02-21
K944345BEDSIDE BUTLERTrac Medical, Inc.1994-10-17
K940223LEARN MODE WATERPROOF PENDANT PANIC BUTTONInteractive Technologies, Inc.1994-04-29
K926029INFRA-LINKZygo Industries, Inc.1993-03-26
K921528HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEMHill-Rom, Inc.1992-04-20
K911101TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEMZofcom, Inc.1991-04-25
K902664HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1Prentke Romich Co.1990-07-25
K901028ENVIRONMENTAL CONTROL UNIT MODEL 7000Baylor Biomedical Services1990-03-13
K900969REMOTE CONTROL SWITCHBaylor Biomedical Services1990-03-13
K881634SIMPLICITY SERIES 5Quartet Technology, Inc.1988-05-17
K873612IMSI, VITAL CALLIntl. Management Services, Inc.1987-11-23

Legacy Summary#

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FDA Review#

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