PED ALERT— 510(k) K950656

Substantially Equivalent

Orbitec Technologies Corp.

FDA 510(k) clearance K950656 for PED ALERT, Substantially Equivalent on 1995-10-25. Applicant: Orbitec Technologies Corp.. Device class: 2.

Clearance details

Applicant: Orbitec Technologies Corp.
Product code: Code IRN
Device class: Class 2
Regulation: 21 CFR 890.5575
Advisory panel: Physical Medicine
Date received: 1995-02-13
Decision date: 1995-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, 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.