Aviator Transport Incubator
FDA 510(k) K081399 · International Biomedical, Ltd.
510(k) numberK081399
Submission
- Device name
- Aviator Transport Incubator
- Applicant
- International Biomedical, Ltd.
Austin, TX, US - Received
- May 19, 2008
- Decision date
- June 6, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| 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 Aviator Transport Incubator cleared by the FDA?
Aviator Transport Incubator (K081399) received a 510(k) decision of Substantially Equivalent on June 6, 2008, 18 days after the submission was received.
What is the product code of K081399?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.