CS2000 & CS2000 TOMO— 510(k) K973834

Substantially Equivalent

Pausch Corp.

FDA 510(k) clearance K973834 for CS2000 & CS2000 TOMO, Substantially Equivalent on 1998-04-30. Applicant: Pausch Corp.. Device class: 2.

Clearance details

Applicant: Pausch Corp.
Product code: Code IZF
Device class: Class 2
Regulation: 21 CFR 892.1740
Advisory panel: Radiology
Date received: 1997-10-08
Decision date: 1998-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tenton Falls, NJ, US

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Recent devices under product code IZF

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