GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)— 510(k) K873121

Name: FDA 510(k) clearance K873121
Creator: U.S. Food and Drug Administration
Published: 1988-08-23

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K873121 for GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS), Substantially Equivalent on 1988-08-23. Applicant: General Electric Co.. Device class: 1.

Clearance details

Applicant: General Electric Co.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1987-08-11
Decision date: 1988-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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