FDA Browser
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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
ETK
Tube, Toynbee Diagnostic
1
Product Code
ETM
Gustometer, Sterile
1
Product Code
ETN
Stimulator, Nerve
2
Product Code
ETP
Stimulator, Caloric-Water
1
Product Code
ETR
Adaptor, Short Increment Sensitivity Index (Sisi)
1
Product Code
ETS
Generator, Electronic Noise (For Audiometric Testing)
2
Product Code
K
81
3557
AUDITORY STIMULATOR
2
Cleared 510(K)
K
81
1790
OCTOTOXIC SCREENER
2
Cleared 510(K)
K
81
1772
AUDITORY LOCALIZER
2
Cleared 510(K)
K
79
0064
TINNITUS DEVICES
2
Cleared 510(K)
K
77
1188
REVERSING CLICK GENERATOR RCG6
2
Cleared 510(K)
ETT
Cushion, Earphone (For Audiometric Testing)
1
Product Code
ETY
Tester, Auditory Impedance
2
Product Code
EWA
Set, Audiometer Calibration
1
Product Code
EWC
Chamber, Acoustic (For Audiometric Testing)
1
Product Code
EWO
Audiometer
2
Product Code
KHH
Stimulator, Caloric-Air
1
Product Code
KLX
Electroglottograph
2
Product Code
LYN
Apparatus, Visual Reinforcement Audiometric
2
Product Code
NAS
Tympanometer
2
Product Code
NNJ
Gustometer, Non-Sterile
1
Product Code
NRK
Kit, Test, Olfactory
2
Product Code
PTO
Tester, Auditory Impedance, Exempt
2
Product Code
PTP
Tympanometer, Exempt
2
Product Code
LWI
Ultrasound, Sinus
2
Product Code
PSV
Ultrasound Bronchoscope
2
Product Code
QJG
Device System, Imaging, Tympanic Membrane And Middle Ear
2
Product Code
QQE
Image Management Software For Planning Of Otologic And Neurotologic Procedures
2
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
EN
/
subpart-b—diagnostic-devices
/
ETS
/
K811772
View Source
AUDITORY LOCALIZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K811772
510(k) Type
Traditional
Applicant
WESTERN ADVANCED TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/15/1981
Days to Decision
23 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
ETK
Tube, Toynbee Diagnostic
ETM
Gustometer, Sterile
ETN
Stimulator, Nerve
ETP
Stimulator, Caloric-Water
ETR
Adaptor, Short Increment Sensitivity Index (Sisi)
ETS
Generator, Electronic Noise (For Audiometric Testing)
K
81
3557
AUDITORY STIMULATOR
K
81
1790
OCTOTOXIC SCREENER
K
81
1772
AUDITORY LOCALIZER
K
79
0064
TINNITUS DEVICES
K
77
1188
REVERSING CLICK GENERATOR RCG6
ETT
Cushion, Earphone (For Audiometric Testing)
ETY
Tester, Auditory Impedance
EWA
Set, Audiometer Calibration
EWC
Chamber, Acoustic (For Audiometric Testing)
EWO
Audiometer
KHH
Stimulator, Caloric-Air
KLX
Electroglottograph
LYN
Apparatus, Visual Reinforcement Audiometric
NAS
Tympanometer
NNJ
Gustometer, Non-Sterile
NRK
Kit, Test, Olfactory
PTO
Tester, Auditory Impedance, Exempt
PTP
Tympanometer, Exempt
LWI
Ultrasound, Sinus
PSV
Ultrasound Bronchoscope
QJG
Device System, Imaging, Tympanic Membrane And Middle Ear
QQE
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
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
EN
/
subpart-b—diagnostic-devices
/
ETS
/
K811772
View Source
AUDITORY LOCALIZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K811772
510(k) Type
Traditional
Applicant
WESTERN ADVANCED TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/15/1981
Days to Decision
23 days