SCD(R) CONTROLLER— 510(k) K933259

Name: FDA 510(k) clearance K933259
Creator: U.S. Food and Drug Administration
Published: 1993-09-13

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K933259 for SCD(R) CONTROLLER, Substantially Equivalent on 1993-09-13. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 2.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1993-07-06
Decision date: 1993-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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