SREE MRI Transport Incubator
FDA 510(k) K161918 · Advanced Imaging Research Dba Sree Medical Systems
510(k) numberK161918
Submission
- Device name
- SREE MRI Transport Incubator
- Applicant
- Advanced Imaging Research Dba Sree Medical Systems
Cleveland, OH, US - Received
- July 13, 2016
- Decision date
- March 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| 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 |
|---|---|---|
| K113365 | Infant ArrayMOS · Traditional | 03/29/2012SE |
Questions and answers
When was SREE MRI Transport Incubator cleared by the FDA?
SREE MRI Transport Incubator (K161918) received a 510(k) decision of Substantially Equivalent on March 3, 2017, 233 days after the submission was received.
What is the product code of K161918?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.