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

Clearance details

Applicant

Elscint, Inc.

Product code

Code MOS

Device class

Class 2

Regulation

21 CFR 892.1000

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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