The following data is part of a premarket notification filed by Advanced Imaging Research Dba Sree Medical Systems with the FDA for Sree Mri Transport Incubator.
| Device ID | K161918 |
| 510k Number | K161918 |
| Device Name: | SREE MRI Transport Incubator |
| Classification | Incubator, Neonatal Transport |
| Applicant | ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS PO BOX 603220 Cleveland, OH 44103 |
| Contact | Ravi Srinivasan |
| Correspondent | Ravi Srinivasan ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS PO BOX 603220 Cleveland, OH 44103 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-13 |
| Decision Date | 2017-03-03 |
| Summary: | summary |