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510(k) K874081

Device
ENTERSCAN
Applicant
PIE DATA MEDICAL BV
510(k) number
K874081
Product code
LWI  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-31
Date received
1987-10-07
Regulation
892.1560
Classification name
Ultrasound, Sinus
Medical specialty
Radiology
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
P. J RIKERS
Address
Philipsweg 1 Maastricht 6227 Aj NL

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LWI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960421SINUSCAN 102/SINUSPRINTFerguson Medical1997-04-16
K960044ULTRAMAX/MODEL NUMBER A1Entlab OY1996-08-02
K960241CPR GENERAL SURGERY TRAYCustom Pack Reliability1996-03-22

Legacy Summary#

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FDA Review#

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