P2900 X-RAY GENERATOR— 510(k) K921516

Name: FDA 510(k) clearance K921516
Creator: U.S. Food and Drug Administration
Published: 1992-05-28

Substantially Equivalent

Precise Optics Photo Medic Equipment, Inc.

FDA 510(k) clearance K921516 for P2900 X-RAY GENERATOR, Substantially Equivalent on 1992-05-28. Applicant: Precise Optics Photo Medic Equipment, Inc.. Device class: 1.

Clearance details

Applicant: Precise Optics Photo Medic Equipment, Inc.
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1992-03-31
Decision date: 1992-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bay Shore, NY, US

Download summary PDF View on FDA.gov ↗

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