OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM— 510(k) K011549

Name: FDA 510(k) clearance K011549
Creator: U.S. Food and Drug Administration
Published: 2001-07-19

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K011549 for OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM, Substantially Equivalent on 2001-07-19. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2001-05-18
Decision date: 2001-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K011549

K-number listed on FDA's recall record

Z-1503-2017 — Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospitalClass II·Terminated·Ohmeda Medical·20161118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011549.

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