FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
ESI
Polymer, Natural-Absorbable Gelatin Material
3
Product Code
EWD
Protector, Hearing (Insert)
U
Product Code
EWE
Protector, Hearing (Circumaural)
U
Product Code
LEZ
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
U
Product Code
LFA
Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
U
Product Code
LFB
Button, Nasal Septal
U
Product Code
LRA
Hearing Aid, Tactile
U
Product Code
K
88
3853
ETA
U
Cleared 510(K)
K
86
2471
WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
U
Cleared 510(K)
K
85
1441
TACTICON 1600
U
Cleared 510(K)
K
85
1655
TEACHER TM
U
Cleared 510(K)
K
84
3433
KANIEVSKI SENSORY AID OR DEVICE
U
Cleared 510(K)
K
83
1501
TACTIL EAR
U
Cleared 510(K)
K
83
0418
TACTAID
U
Cleared 510(K)
K
81
3057
VIBRO-COM COMMUNICATOR #8827
U
Cleared 510(K)
LXV
Apparatus, Vestibular Analysis
U
Product Code
MCM
Implant, Cochlear
3
Product Code
MHE
Implant, Auditory Brainstem
3
Product Code
MJV
Device, Inflation, Middle Ear
U
Product Code
MPV
Implant, Hearing, Active, Middle Ear, Partially Implanted
3
Product Code
MRK
System, Imaging, Fluorescence
3
Product Code
QNU
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
2
Product Code
OAA
Aid, Visual, For Nausea
N
Product Code
QLV
Field Generator Positioning Device
1
Product Code
EPG
Stimulator, Transdermal
3
Product Code
OAF
Implant, Hearing, Active, Middle Ear, Totally Implanted
3
Product Code
OAQ
Electronic Media, Hyperacusis
N
Product Code
OWO
Drug-Eluting Sinus Stent
3
Product Code
PGQ
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
3
Product Code
QJA
Tympanostomy Tube Delivery Product With Drug
3
Product Code
QOO
Ventilator Tubing And Accessories
N
Product Code
QOP
Respiratory Humidifier For Emergency Use
N
Product Code
QOS
Continuous Ventilator
N
Product Code
QOT
Emergency Ventilator
N
Product Code
QOV
Critical Care Ventilator
N
Product Code
QOX
Multi-Patient Circuit Connector
N
Product Code
QQG
Oropharyngeal Electrical Stimulator
2
Product Code
QVN
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
2
Product Code
QXG
Cooperative Powered Surgical Assist Device For Ent Surgery
2
Product Code
QZC
External Mechanical Stimulator For The Relief Of Congestion
2
Product Code
SCR
Air-Conduction Hearing Aid Software
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
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 30 November 2024 at 11:09 am
EN
/
EN-misc
/
LRA
/
K843433
View Source
KANIEVSKI SENSORY AID OR DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843433
510(k) Type
Traditional
Applicant
SPECTRO INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/1984
Days to Decision
71 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
ESI
Polymer, Natural-Absorbable Gelatin Material
EWD
Protector, Hearing (Insert)
EWE
Protector, Hearing (Circumaural)
LEZ
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
LFA
Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
LFB
Button, Nasal Septal
LRA
Hearing Aid, Tactile
K
88
3853
ETA
K
86
2471
WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
K
85
1441
TACTICON 1600
K
85
1655
TEACHER TM
K
84
3433
KANIEVSKI SENSORY AID OR DEVICE
K
83
1501
TACTIL EAR
K
83
0418
TACTAID
K
81
3057
VIBRO-COM COMMUNICATOR #8827
LXV
Apparatus, Vestibular Analysis
MCM
Implant, Cochlear
MHE
Implant, Auditory Brainstem
MJV
Device, Inflation, Middle Ear
MPV
Implant, Hearing, Active, Middle Ear, Partially Implanted
MRK
System, Imaging, Fluorescence
QNU
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
OAA
Aid, Visual, For Nausea
QLV
Field Generator Positioning Device
EPG
Stimulator, Transdermal
OAF
Implant, Hearing, Active, Middle Ear, Totally Implanted
OAQ
Electronic Media, Hyperacusis
OWO
Drug-Eluting Sinus Stent
PGQ
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
QJA
Tympanostomy Tube Delivery Product With Drug
QOO
Ventilator Tubing And Accessories
QOP
Respiratory Humidifier For Emergency Use
QOS
Continuous Ventilator
QOT
Emergency Ventilator
QOV
Critical Care Ventilator
QOX
Multi-Patient Circuit Connector
QQG
Oropharyngeal Electrical Stimulator
QVN
Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
QXG
Cooperative Powered Surgical Assist Device For Ent Surgery
QZC
External Mechanical Stimulator For The Relief Of Congestion
SCR
Air-Conduction Hearing Aid Software
Submissions with No Product Code
Subpart B—Diagnostic Devices
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
/
EN-misc
/
LRA
/
K843433
View Source
KANIEVSKI SENSORY AID OR DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843433
510(k) Type
Traditional
Applicant
SPECTRO INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/1984
Days to Decision
71 days