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 |