ORION PLATINUM— 510(k) K003367

Substantially Equivalent

Srs Medical Systems, Inc.

FDA 510(k) clearance K003367 for ORION PLATINUM, Substantially Equivalent on 2001-01-04. Applicant: Srs Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Srs Medical Systems, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2000-10-30
Decision date: 2001-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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