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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
PDQ
Neurosurgical Nerve Locator
2
Product Code
HRW
Dynamometer, Nonpowered
1
Product Code
KQW
Goniometer, Nonpowered
1
Product Code
KQX
Goniometer, Ac-Powered
1
Product Code
LBB
Dynamometer, Ac-Powered
2
Product Code
NKI
Goniometer With Electrodes
2
Product Code
K
03
3193
SONOSENS
2
Cleared 510(K)
QWP
Optical Neurosurgical Nerve Locator
2
Product Code
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
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CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
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Unknown
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Last synced on 31 January 2025 at 11:05 pm
NE
/
subpart-b—diagnostic-devices
/
NKI
/
K033193
View Source
SONOSENS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033193
510(k) Type
Abbreviated
Applicant
FRIENDLY SENSORS AG
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/23/2004
Days to Decision
113 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
PDQ
Neurosurgical Nerve Locator
HRW
Dynamometer, Nonpowered
KQW
Goniometer, Nonpowered
KQX
Goniometer, Ac-Powered
LBB
Dynamometer, Ac-Powered
NKI
Goniometer With Electrodes
K
03
3193
SONOSENS
QWP
Optical Neurosurgical Nerve Locator
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
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—diagnostic-devices
/
NKI
/
K033193
View Source
SONOSENS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033193
510(k) Type
Abbreviated
Applicant
FRIENDLY SENSORS AG
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/23/2004
Days to Decision
113 days
Submission Type
Summary