Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-SAFB-SM, HHS-SPFB-USA

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K100523 ↗

FDA Product Code

NMD

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Hygia Health Services, Inc. →

• What is the purpose of the Cerebral-Somatic Oximetry Sensor?

  The sensor is designed to non-invasively monitor site-specific adequacy of perfusion in the brain or body tissue directly beneath the sensors, providing real-time data on regional oxygen saturation (rSO2) to detect ischemic complications.

• What models are available for the Cerebral-Somatic Oximetry Sensor?

  The sensor is available in various models including HHS-SAFB-SM and HHS-SPFB-USA, specifically designed for use with the INVOS oximeter system to monitor oxygen saturation in different patient populations.

• Is the Cerebral-Somatic Oximetry Sensor cleared for medical use?

  Yes, the device has received FDA 510(k) clearance with a product code of NMD and is classified under device class 2 for oximeter, tissue saturation, and reprocessed devices.

• How is the Cerebral-Somatic Oximetry Sensor supplied?

  The sensor is supplied in various models including HHS-SAFB-SM and HHS-SPFB-USA, designed for compatibility with the INVOS oximeter system to provide accurate regional oxygen saturation measurements.