PHOTON RADIOSURGERY SYSTEM (PRS)— 510(k) K964947

Name: FDA 510(k) clearance K964947
Creator: U.S. Food and Drug Administration
Published: 1997-06-20

Substantially Equivalent

Photoelectron Corporation

FDA 510(k) clearance K964947 for PHOTON RADIOSURGERY SYSTEM (PRS), Substantially Equivalent on 1997-06-20. Applicant: Photoelectron Corporation. Device class: 2.

Clearance details

Applicant: Photoelectron Corporation
Product code: Code JAD
Device class: Class 2
Regulation: 21 CFR 892.5900
Advisory panel: Radiology
Date received: 1996-12-10
Decision date: 1997-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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