FULCRUM— 510(k) K021949

Substantially Equivalent

Howtek, Inc.

FDA 510(k) clearance K021949 for FULCRUM, Substantially Equivalent on 2002-08-12. Applicant: Howtek, Inc.. Device class: 2.

Clearance details

Applicant: Howtek, Inc.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 2002-06-13
Decision date: 2002-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LMA

K132183 — DICOM VIDEO2013-10-03
K130636 — TELERADPRO EDGE; TELERADPRO EDGE HD-CCD2013-06-07
K130406 — DIAGNOSTICPRO EDGE2013-04-29
K102476 — TELERADPRO2010-10-07
K093809 — VIDAR DENTAL FILM DIGITIZER2010-01-07

More clearances from Howtek, Inc.

K973081 — DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)1997-11-05
K972191 — DIGITIZER DIRECTOR (HSC025-01)1997-09-08
K970908 — HOWTEK 9601997-05-20
K953117 — SCANMASTER DX1996-01-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.