The following data is part of a premarket notification filed by International Biomedical, Ltd. with the FDA for Voyager Transport Incubator With Masimo Pulseox, Voyager Transport Incubator With Nellcor Pulseox.
| Device ID | K103524 |
| 510k Number | K103524 |
| Device Name: | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
| Classification | Incubator, Neonatal Transport |
| Applicant | INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. Austin, TX 78754 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-01 |
| Decision Date | 2011-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868406000020 | K103524 | 000 |