KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM— 510(k) K852543

Clearance details

Applicant

Kontron Instruments, Inc.

Product code

Code DXK

Device class

Class 2

Regulation

21 CFR 870.2330

Advisory panel

Cardiovascular

Date received

1985-06-14

Decision date

1985-09-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Everett, MA, US

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