# FDA 483 - SensorMedics Corporation - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/sensormedics-corporation/821e8f71-c0bc-4726-abb1-cb27b8949c1a

> FDA 483 for SensorMedics Corporation on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SensorMedics Corporation
- Product Type: device
- Office Name: Human Foods Program
- Summary: 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: https://www.globalkeysolutions.net/companies/sensormedics-corporation/d59f6bb5-b383-4599-bf4a-8e016d46e141

Office: https://www.globalkeysolutions.net/offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324