QUANTEM— 510(k) K963162

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K963162 for QUANTEM, Substantially Equivalent on 1996-11-12. Applicant: Elscint, Inc.. Device class: 2.

Clearance details

Applicant: Elscint, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1996-08-14
Decision date: 1996-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.