A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor Pulseox
FDA 510(k) K103525 · International Biomedical, Ltd.
510(k) numberK103525
Submission
- Device name
- A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor Pulseox
- Applicant
- International Biomedical, Ltd.
Austin, TX, US - Received
- December 1, 2010
- Decision date
- May 11, 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
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|---|---|---|---|
| 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 |
| 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 |
| K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager 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 |
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| 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 |
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| K173516 | NuBorne Infant WarmerFMT · Abbreviated | 08/17/2018SE |
| K160238 | Airborne Phototherapy LightLBI · Abbreviated | 06/14/2016SE |
| K140707 | Lifeborne Infant ResuscitatorBTL · Traditional | 05/28/2014SE |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…FPL · Special | 05/11/2011SE |
| K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with…FPL · Special | 04/15/2011SE |
Questions and answers
When was A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor Pulseox cleared by the FDA?
A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor Pulseox (K103525) received a 510(k) decision of Substantially Equivalent on May 11, 2011, 161 days after the submission was received.
What is the product code of K103525?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.