LED HEADLIGHT— 510(k) K031548

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K031548 for LED HEADLIGHT, Substantially Equivalent on 2003-08-11. Applicant: Welch Allyn, Inc.. Device class: 2.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code FSR
Device class: Class 2
Regulation: 21 CFR 886.4335
Advisory panel: Ophthalmic
Date received: 2003-05-16
Decision date: 2003-08-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSR

K110528 — INTEGRA LED SURGICAL HEADLIGHT SYSTEM2011-05-11
K031549 — SOLID STATE LAMP [LED] HEADLIGHT2003-08-11
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Data sourced from openFDA. This site is unofficial and independent of the FDA.