NOTTA AMBULATORY RECORDER— 510(k) K013450

Substantially Equivalent

Stellate Systems

FDA 510(k) clearance K013450 for NOTTA AMBULATORY RECORDER, Substantially Equivalent on 2002-01-14. Applicant: Stellate Systems. Device class: 2.

Clearance details

Applicant: Stellate Systems
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-10-17
Decision date: 2002-01-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Westmount, Quebec, CA

Download summary PDF View on FDA.gov ↗

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