Submission Details
| 510(k) Number | K103525 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 2010 |
| Decision Date | May 11, 2011 |
| Days to Decision | 161 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
May 2011
Decision
161d
Days
Class 2
Risk
About This 510(k) Submission
K103525 is an FDA 510(k) clearance for the A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR 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 May 11, 2011, 161 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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