FDA.report

510(k) K021949

Device
FULCRUM
Applicant
Howtek, Inc.
510(k) number
K021949
Product code
LMA
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-12
Date received
2002-06-13
Regulation
892.2030
Classification name
Digitizer, Image, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOHN E ROSENSTENGEL
Address
21 Park Ave. Hudson NH US 03051 03051

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K013395LIFEJET VIDEO LINKFerrania S.P.A.2001-10-30
K011049EXPRESSSUITEVidar Systems Corp.2001-10-01