SIMULIX-HP— 510(k) K946128

Substantially Equivalent

Oldelft Corp. of America

FDA 510(k) clearance K946128 for SIMULIX-HP, Substantially Equivalent on 1995-05-12. Applicant: Oldelft Corp. of America. Device class: 2.

Clearance details

Applicant: Oldelft Corp. of America
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 1994-12-15
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Oldelft Corp. of America

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K923584 — THERAPAX DXT 300 SERIES 31993-01-15

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