WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600— 510(k) K991627

Name: FDA 510(k) clearance K991627
Creator: U.S. Food and Drug Administration
Published: 1999-05-17

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K991627 for WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600, Substantially Equivalent on 1999-05-17. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Respironics, Inc.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1999-05-11
Decision date: 1999-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.