CRITERION 60 OR PM 60— 510(k) K000959

Substantially Equivalent

Caradyne, Ltd.

FDA 510(k) clearance K000959 for CRITERION 60 OR PM 60, Substantially Equivalent on 2000-06-22. Applicant: Caradyne, Ltd.. Device class: 2.

Clearance details

Applicant: Caradyne, Ltd.
Product code: Code CAP
Device class: Class 2
Regulation: 21 CFR 868.2600
Advisory panel: Anesthesiology
Date received: 2000-03-24
Decision date: 2000-06-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mccordsville, IN, 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.