BIODEX SYSTEM— 510(k) K860821

Substantially Equivalent

Biodex Corp.

FDA 510(k) clearance K860821 for BIODEX SYSTEM, Substantially Equivalent on 1986-04-18. Applicant: Biodex Corp.. Device class: 2.

Clearance details

Applicant: Biodex Corp.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1986-03-04
Decision date: 1986-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Moriches, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biodex Corp.

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K913021 — BIODEX,MODEL B-20001991-10-03
K900450 — BIODEX LIFT SIMULATOR1990-07-24

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