Submission Details
| 510(k) Number | K103524 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 2010 |
| Decision Date | April 15, 2011 |
| Days to Decision | 135 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
Apr 2011
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K103524 is an FDA 510(k) clearance for the VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX, a Incubator, Neonatal Transport (Class II — Special Controls, product code FPL), submitted by International Biomedical, Ltd. (Austin, US). The FDA issued a Cleared decision on April 15, 2011, 135 days after receiving the submission on December 1, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5410.
Device Classification
| Product Code | FPL — Incubator, Neonatal Transport |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5410 |
Manufacturer
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