HEARTCARD, MODEL 5258— 510(k) K010945

Substantially Equivalent

Instromedix

FDA 510(k) clearance K010945 for HEARTCARD, MODEL 5258, Substantially Equivalent on 2001-06-12. Applicant: Instromedix.

Clearance details

Applicant: Instromedix
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2001-03-29
Decision date: 2001-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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