ELK LASER FILM DIGITIZER— 510(k) K984409

Name: FDA 510(k) clearance K984409
Creator: U.S. Food and Drug Administration
Published: 1999-02-12

Substantially Equivalent

Nishimoto Sangyo Co., Ltd.

FDA 510(k) clearance K984409 for ELK LASER FILM DIGITIZER, Substantially Equivalent on 1999-02-12. Applicant: Nishimoto Sangyo Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nishimoto Sangyo Co., Ltd.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 1998-12-09
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

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