AMEDA PHOTOTHERAPY LAMP FOR NEWBORN— 510(k) K834335

Name: FDA 510(k) clearance K834335
Creator: U.S. Food and Drug Administration
Published: 1984-04-20

Substantially Equivalent

Egnell, Inc.

FDA 510(k) clearance K834335 for AMEDA PHOTOTHERAPY LAMP FOR NEWBORN, Substantially Equivalent on 1984-04-20. Applicant: Egnell, Inc.. Device class: 2.

Clearance details

Applicant: Egnell, Inc.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1983-12-12
Decision date: 1984-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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