Cleared Traditional

SREE MRI Transport Incubator

K161918 · Advanced Imaging Research Dba Sree Medical Systems · General Hospital

Mar 2017

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K161918 is an FDA 510(k) clearance for the SREE MRI Transport Incubator, a Incubator, Neonatal Transport (Class II — Special Controls, product code FPL), submitted by Advanced Imaging Research Dba Sree Medical Systems (Cleveland, US). The FDA issued a Cleared decision on March 3, 2017, 233 days after receiving the submission on July 13, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5410.

Submission Details

510(k) Number	K161918 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2016
Decision Date	March 03, 2017
Days to Decision	233 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF