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Cutaneous Electrode Pair 2” x 2”
AXIOBIONICS
2
In Commercial Distribution
- B367118P20 ()
115P
- Transcutaneous electrical stimulation electrode, single-use
Cutaneous Electrode Pair 1.5” x 2”
AXIOBIONICS
2
In Commercial Distribution
- B367117P20 ()
117P
- Transcutaneous electrical stimulation electrode, single-use
Cutaneous Electrode Pair 1.5” x 1.5”
AXIOBIONICS
2
In Commercial Distribution
- B367116P20 ()
116P
- Transcutaneous electrical stimulation electrode, single-use
Cutaneous Electrode Pair 1.25” x 1.25”
AXIOBIONICS
2
In Commercial Distribution
- B367115P20 ()
115P
- Transcutaneous electrical stimulation electrode, single-use
The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System
analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during
sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders,
where it may inform or drive clinical management for children, adolescents and adults.
The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare
professionals in diagnosis and management of sleep disordered breathing.
The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified
healthcare professional.
MYCARDIO LLC
2
In Commercial Distribution
- B315SLEEPIMAGESYSTEMD8 ()
- Sleep disorder interpretive software, professional-only
No Description
Gulden Ophthalmics Inc.
2
In Commercial Distribution
- B091230120 ()
- B091230122 ()
23012
- Corneal shield applicator
Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of the CYP2C19 alleles, in three separate tubes. Each tube is specific for the detection of one of the three CYP2C19 loci.
One box of Test Kit, cartridges contains 20 cartridges; one cartridge per pouch.
The Genomadix Cube CYP2C19 Test is indicated for use with the Genomadix Cube CYP2C19 Platform.
Genomadix Inc
2
In Commercial Distribution
- ASM00101 ()
- Nucleic acid amplification mastermix kit IVD
Uni Tibial Tray Size 2
SIGNAL MEDICAL CORPORATION
2
In Commercial Distribution
- B046WZ110120 ()
WZ-1-1012
- Coated unicondylar knee tibia prosthesis
Uni Femoral Knee Size 2
SIGNAL MEDICAL CORPORATION
2
In Commercial Distribution
- B046WZ110020 ()
WZ-1-1002
- Coated knee femur prosthesis
No Description
MATH RESOLUTIONS, LLC
2
In Commercial Distribution
- B229RTDP21 ()
- Radiation therapy software