KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS— 510(k) K962595

Name: FDA 510(k) clearance K962595
Creator: U.S. Food and Drug Administration
Published: 1996-09-04

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K962595 for KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS, Substantially Equivalent on 1996-09-04. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FFS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1996-07-02
Decision date: 1996-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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