483
SensorMedics CorporationSensorMedics Corporation – FDA 483
Record Details
This document is a 510(k) clearance letter issued to SensorMedics Corporation for their Infant Flow System. The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed subject to general controls and compliance with the Quality System Regulation.
- Company
- SensorMedics Corporation
- Product type
- device
- Office
- Human Foods Program
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ID · 821e8f71-c0bc-4726-abb1-cb27b8949c1a
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