ORLOCATE SYSTEM MODEL ORL 100— 510(k) K100551

Name: FDA 510(k) clearance K100551
Creator: U.S. Food and Drug Administration
Published: 2010-08-12

Substantially Equivalent

Haldor Advanced Technologies, Ltd.

FDA 510(k) clearance K100551 for ORLOCATE SYSTEM MODEL ORL 100, Substantially Equivalent on 2010-08-12. Applicant: Haldor Advanced Technologies, Ltd.. Device class: 1.

Clearance details

Applicant: Haldor Advanced Technologies, Ltd.
Product code: Code LWH
Device class: Class 1
Regulation: 21 CFR 880.2740
Advisory panel: General Hospital
Date received: 2010-02-26
Decision date: 2010-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pardes Hanna, IL

Download summary PDF View on FDA.gov ↗

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