OLDELFT SIMULIX-MC— 510(k) K912466

Substantially Equivalent

Oldelft Corp. of America

FDA 510(k) clearance K912466 for OLDELFT SIMULIX-MC, Substantially Equivalent on 1991-06-28. 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: 1991-06-04
Decision date: 1991-06-28
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

K980296 — OLDELFT DIGIDELCA1998-04-17
K973219 — AMBER DU1997-10-08
K946128 — SIMULIX-HP1995-05-12
K950037 — N 800 HF1995-02-15
K932848 — SIMULIX-MC CT EXTENSION1994-03-22

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