DIGITIZER DIRECTOR (HSC025-01)— 510(k) K972191

Substantially Equivalent

Howtek, Inc.

FDA 510(k) clearance K972191 for DIGITIZER DIRECTOR (HSC025-01), Substantially Equivalent on 1997-09-08. Applicant: Howtek, Inc.. Device class: 1.

Clearance details

Applicant: Howtek, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1997-06-10
Decision date: 1997-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Howtek, Inc.

K021949 — FULCRUM2002-08-12
K973081 — DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)1997-11-05
K970908 — HOWTEK 9601997-05-20
K953117 — SCANMASTER DX1996-01-18

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