2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)— 510(k) K972592

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K972592 for 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101), Substantially Equivalent on 1997-09-15. Applicant: Elscint, Inc..

Clearance details

Applicant: Elscint, Inc.
Product code: Code MOS
Advisory panel: Radiology
Date received: 1997-07-11
Decision date: 1997-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

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