Fore-Sight Absolute Tissue Oximeter

510(k) Number

K112820 ↗

FDA product code

MUD

Device class

Class II

Regulation

21 CFR Part 870.2700

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code MUD (Oximeter, Tissue Saturation).

• T-STAT 303 ISCHEMIA MONITORING SYSTEM by Spectros Corporation
• HyperView Hyperspectral Tissue Oxygenation Measurement System by Hypermed Imaging, Inc.
• 03 Sensor rS02 Large Adhesive Sensor 3756 by MASIMO CORPORATION
• O3 4384 by MASIMO CORPORATION
• Clarifi Imaging System by MODULATED IMAGING INC.
• FORE-SIGHT ELITE Absolute Tissue Oximeter by Edwards Lifesciences LLC
• MOBILE CAREGUIDE 2100 OXIMETER by Reflectance Medical, Inc.
• INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 by Hutchinson Technology, Inc.
• MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 by Hutchinson Technology, Inc.
• Smart Pressure Controller PC1Q by Edwards Lifesciences LLC

• Fore-Sight® 01-07-1007

  Class II

  FDA 510(k) K112820 Active Cleared 26 Jan 2012 GUDID on market

• Fore-Sight Elite 01-06-1100 Open recall

  Class II

  FDA 510(k) K180003 Active Cleared 10 May 2018 GUDID on market

• Fore-Sight® 01-07-1006

  Class II

  FDA 510(k) K112820 Active Cleared 26 Jan 2012 GUDID on market

• Fore-Sight® 01-07-1004

  Class II

  FDA 510(k) K112820 Active Cleared 26 Jan 2012 GUDID on market

See all devices from Cas Medical Systems, Inc. →