NEITZ HALOGEN OPHTHALMOSCOPE BXA-13— 510(k) K942721

Name: FDA 510(k) clearance K942721
Creator: U.S. Food and Drug Administration
Published: 1994-08-05

Substantially Equivalent

Neitz Instruments Company, Ltd.

FDA 510(k) clearance K942721 for NEITZ HALOGEN OPHTHALMOSCOPE BXA-13, Substantially Equivalent on 1994-08-05. Applicant: Neitz Instruments Company, Ltd.. Device class: 2.

Clearance details

Applicant: Neitz Instruments Company, Ltd.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1994-06-09
Decision date: 1994-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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