VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX— 510(k) K103524

Name: FDA 510(k) clearance K103524
Creator: U.S. Food and Drug Administration
Published: 2011-04-15

Substantially Equivalent

International Biomedical, Ltd.

FDA 510(k) clearance K103524 for VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX, Substantially Equivalent on 2011-04-15. Applicant: International Biomedical, Ltd.. Device class: 2.

Clearance details

Applicant: International Biomedical, Ltd.
Product code: Code FPL
Device class: Class 2
Regulation: 21 CFR 880.5410
Advisory panel: General Hospital
Date received: 2010-12-01
Decision date: 2011-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPL

view all

K220742 — NxtGen Infant Transport Incubator2022-07-15
K161918 — SREE MRI Transport Incubator2017-03-03
K141565 — GLOBE-TROTTER GT54002014-09-10
K123937 — ATOM TRANSCAPSULE V-7072013-05-23
K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX2011-05-11

More clearances from International Biomedical, Ltd.

view all

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