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Innolitics
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BSD
Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
3
Product Code
LSZ
Ventilator, High Frequency
3
Product Code
LYM
Device, Cpr Assist
U
Product Code
MNQ
Stimulator, Hypoglossal Nerve, Implanted, Apnea
3
Product Code
NJK
Valve, Pulmonary
3
Product Code
P
18
0007
Spiration® Valve System
APPR
PMA Approval
P
18
0002
Zephyr Endobronchial Valve System
APPR
PMA Approval
OAZ
One-Way Air-Leak Valve
F
Product Code
OIR
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
F
Product Code
OOY
Bronchial Thermoplasty System
3
Product Code
PDR
Computer-Assisted Personalized Sedation System
3
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PNC
Catheter Introducer
N
Product Code
POI
Lung Tissue Sealant For Lung Volume Reduction
N
Product Code
PSR
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
3
Product Code
QGZ
Electrical Tumor Treatment Fields
3
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QKS
Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
N
Product Code
QLI
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N
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QOQ
Non-Continuous Ventilator For Emergency Use
N
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QOR
Continuous Ventilator, Minimal Ventilatory Support
N
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QOU
Emergency Resuscitator
N
Product Code
QOW
Ventilatory Assistance Helmet
N
Product Code
QPR
Neurological Stimulation For Emergency Use
N
Product Code
QRS
Device For Sleep Apnea Testing Based On Mandibular Movement
2
Product Code
QSF
Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
3
Product Code
QRG
Ultrasound Guided Nerve Block Assist
2
Product Code
QVE
Adjunctive Pain Measurement Device For Anesthesiology
2
Product Code
QVT
Monitor For Opioid Induced Impairment Of Oxygenation
2
Product Code
QTB
Nitric Oxide Generator And Delivery System
3
Product Code
QZW
Over-The-Counter Device To Assess Risk Of Sleep Apnea
2
Product Code
QWE
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
2
Product Code
QXD
Spinal Imaging System For Neuraxial Procedures
2
Product Code
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
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Last synced on 16 August 2024 at 11:05 pm
AN
/
AN-misc
/
NJK
/
P180007
View Source
Spiration® Valve System
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
BSD
Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
LSZ
Ventilator, High Frequency
LYM
Device, Cpr Assist
MNQ
Stimulator, Hypoglossal Nerve, Implanted, Apnea
NJK
Valve, Pulmonary
P
18
0007
Spiration® Valve System
P
18
0002
Zephyr Endobronchial Valve System
OAZ
One-Way Air-Leak Valve
OIR
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
OOY
Bronchial Thermoplasty System
PDR
Computer-Assisted Personalized Sedation System
PNC
Catheter Introducer
POI
Lung Tissue Sealant For Lung Volume Reduction
PSR
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
QGZ
Electrical Tumor Treatment Fields
QKS
Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
QLI
Vaporizer, Cder Or Cber Led
QOQ
Non-Continuous Ventilator For Emergency Use
QOR
Continuous Ventilator, Minimal Ventilatory Support
QOU
Emergency Resuscitator
QOW
Ventilatory Assistance Helmet
QPR
Neurological Stimulation For Emergency Use
QRS
Device For Sleep Apnea Testing Based On Mandibular Movement
QSF
Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
QRG
Ultrasound Guided Nerve Block Assist
QVE
Adjunctive Pain Measurement Device For Anesthesiology
QVT
Monitor For Opioid Induced Impairment Of Oxygenation
QTB
Nitric Oxide Generator And Delivery System
QZW
Over-The-Counter Device To Assess Risk Of Sleep Apnea
QWE
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
QXD
Spinal Imaging System For Neuraxial Procedures
Submissions with No Product Code
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
AN-misc
/
NJK
/
P180007
View Source
Spiration® Valve System
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...