RAYDEN MEDICAL MINI PULSE VOLUME RECORD— 510(k) K833155

Name: FDA 510(k) clearance K833155
Creator: U.S. Food and Drug Administration
Published: 1984-01-26

Substantially Equivalent

Burditt & Calkins-Siemens-Elema

FDA 510(k) clearance K833155 for RAYDEN MEDICAL MINI PULSE VOLUME RECORD, Substantially Equivalent on 1984-01-26. Applicant: Burditt & Calkins-Siemens-Elema. Device class: 2.

Clearance details

Applicant: Burditt & Calkins-Siemens-Elema
Product code: Code DSB
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 1983-09-15
Decision date: 1984-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.