Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox
FDA 510(k) K103524 · International Biomedical, Ltd.
510(k) numberK103524
Submission
- Device name
- Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox
- Applicant
- International Biomedical, Ltd.
Austin, TX, US - Received
- December 1, 2010
- Decision date
- April 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPL – Incubator, Neonatal Transport
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5410
- Specialty
- General Hospital
Other 510(k)s with product code FPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220742 | NxtGen Infant Transport IncubatorFPL · Traditional | International Biomedical | 07/15/2022SE |
| K161918 | SREE MRI Transport IncubatorFPL · Traditional | Advanced Imaging Research Dba Sree Medical Systems | 03/03/2017SE |
| K141565 | Globe-Trotter GT5400FPL · Traditional | Draeger Medical Systems, Inc. | 09/10/2014SE |
| K123937 | Atom Transcapsule V-707FPL · Traditional | Atom Medical Corporation | 05/23/2013SE |
| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| K081399 | Aviator Transport IncubatorFPL · Special | International Biomedical, Ltd. | 06/06/2008SE |
| K061071 | V-808 Atom TranscapsuleFPL · Traditional | Atom Medical, Inc. | 08/29/2006SE |
| K062052 | LMT Nomag Ic 3.0FPL · Traditional | Lmt Lammers Medical Technology GmbH | 07/31/2006SE |
More from Lmt Lammers Medical Technology GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler®MPO · Traditional | 10/07/2022SE |
| K221653 | InfaTherm Disposable Infant Warming MattressIMD · Traditional | 10/06/2022SE |
| K220742 | NxtGen Infant Transport IncubatorFPL · Traditional | 07/15/2022SE |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemMRN · Special | 03/10/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | 01/18/2019SE |
| K173516 | NuBorne Infant WarmerFMT · Abbreviated | 08/17/2018SE |
| K160238 | Airborne Phototherapy LightLBI · Abbreviated | 06/14/2016SE |
| K140707 | Lifeborne Infant ResuscitatorBTL · Traditional | 05/28/2014SE |
| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…FPL · Special | 05/11/2011SE |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…FPL · Special | 05/11/2011SE |
Questions and answers
When was Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox cleared by the FDA?
Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox (K103524) received a 510(k) decision of Substantially Equivalent on April 15, 2011, 135 days after the submission was received.
What is the product code of K103524?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.