SPOT-FILM DEVICE 8835— 510(k) K842184

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K842184 for SPOT-FILM DEVICE 8835, Substantially Equivalent on 1984-07-17. Applicant: General Electric Co.. Device class: 2.

Clearance details

Applicant: General Electric Co.
Product code: Code IXL
Device class: Class 2
Regulation: 21 CFR 892.1670
Advisory panel: Radiology
Date received: 1984-06-01
Decision date: 1984-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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