CARDIOCAP(TM) DR-104 REPORTER— 510(k) K885058

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K885058 for CARDIOCAP(TM) DR-104 REPORTER, Substantially Equivalent on 1989-07-14. Applicant: Datex Division Instrumentarium Corp..

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code DSF
Advisory panel: Cardiovascular
Date received: 1988-12-07
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

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