GAMMA GUIDANCE SYSTEM— 510(k) K961321

Name: FDA 510(k) clearance K961321
Creator: U.S. Food and Drug Administration
Published: 1997-02-10

Substantially Equivalent

Radiation Monitoring Devices, Inc.

FDA 510(k) clearance K961321 for GAMMA GUIDANCE SYSTEM, Substantially Equivalent on 1997-02-10. Applicant: Radiation Monitoring Devices, Inc.. Device class: 1.

Clearance details

Applicant: Radiation Monitoring Devices, Inc.
Product code: Code IZD
Device class: Class 1
Regulation: 21 CFR 892.1320
Advisory panel: Radiology
Date received: 1996-04-05
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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