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Subpart B—Cardiovascular Diagnostic Devices
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Subpart F—Therapeutic Devices
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QHH
Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
2
Product Code
K
24
1533
NeurAxis IB-Stim (01-1020)
2
Cleared 510(K)
K
23
0526
TEA Device
2
Cleared 510(K)
K
20
2940
First Relief v1
2
Cleared 510(K)
DEN
18
0057
IB-Stim
2
Cleared 510(K)
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Last synced on 6 December 2024 at 11:05 pm
NE
/
subpart-f—therapeutic-devices
/
QHH
/
K241533
View Source
NeurAxis IB-Stim (01-1020)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241533
510(k) Type
Traditional
Applicant
NeurAxis
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2024
Days to Decision
153 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical 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
QHH
Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
K
24
1533
NeurAxis IB-Stim (01-1020)
K
23
0526
TEA Device
K
20
2940
First Relief v1
DEN
18
0057
IB-Stim
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-f—therapeutic-devices
/
QHH
/
K241533
View Source
NeurAxis IB-Stim (01-1020)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241533
510(k) Type
Traditional
Applicant
NeurAxis
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2024
Days to Decision
153 days
Submission Type
Summary