FDA Browser
by
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
ETT
Cushion, Earphone (For Audiometric Testing)
1
Product Code
ETY
Tester, Auditory Impedance
2
Product Code
K
18
3201
Hearing Healthcare Pro
2
Cleared 510(K)
K
17
1038
Hearing Healthcare Pro
2
Cleared 510(K)
K
16
2210
touchTymp
2
Cleared 510(K)
K
16
1707
Madsen Zodiac
2
Cleared 510(K)
K
15
1616
AT235
2
Cleared 510(K)
K
15
1509
GSI TympStar Pro Middle Ear Analyzer
2
Cleared 510(K)
K
13
3013
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
2
Cleared 510(K)
K
12
1847
TITAN
2
Cleared 510(K)
K
08
3861
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
2
Cleared 510(K)
K
08
1841
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
2
Cleared 510(K)
K
07
0312
EARCHECK ACOUSTIC REFLECTOMETER
2
Cleared 510(K)
K
03
3645
OTOFLEX 100 TYE 1012
2
Cleared 510(K)
K
03
1978
AMPLAID A756 SCREENING ADMITTANCE METER
2
Cleared 510(K)
K
02
2728
AUDIOTRAVELLER, MODEL AA222
2
Cleared 510(K)
K
00
0097
GSI 2000 MIDDLE EAR ANALYZER
2
Cleared 510(K)
K
99
4254
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
99
1562
PASCAL MEDICAL AB MENIETT 20
2
Cleared 510(K)
K
99
2370
AMPLAID A724 AND A728
2
Cleared 510(K)
K
99
0652
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
99
0585
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
98
3832
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
98
3051
AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
2
Cleared 510(K)
K
98
3049
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
2
Cleared 510(K)
K
98
3046
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
2
Cleared 510(K)
K
97
4235
AMPLAID AM50
2
Cleared 510(K)
K
97
1859
EARCHECK
2
Cleared 510(K)
K
97
0685
EARCHECK PRO
2
Cleared 510(K)
K
95
5289
RACE CAR TYMPANOMETER
2
Cleared 510(K)
K
95
3161
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
2
Cleared 510(K)
K
94
2007
INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26
2
Cleared 510(K)
K
94
2008
INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
93
0165
AE-207D TYMPANOMETER
2
Cleared 510(K)
K
93
0164
THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S
2
Cleared 510(K)
K
92
3072
HANDTYMP
2
Cleared 510(K)
K
92
3073
AUTOMATIC TYMPANOMETER
2
Cleared 510(K)
K
92
5585
GSI 38 AUTO TYMP
2
Cleared 510(K)
K
92
4934
AUTOMATIC IMPEDANCE METER AE-205
2
Cleared 510(K)
K
92
4933
AE-206 TYMPNOMWRWE(R) AUDIOMETER
2
Cleared 510(K)
K
91
0247
ZODIAC 901 MIDDLE-EAR ANALYZER
2
Cleared 510(K)
K
90
5704
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
2
Cleared 510(K)
K
91
1095
GSI 37 AUTO TYMP
2
Cleared 510(K)
K
90
5213
MIDDLE EAR ANALYZER, MODEL AE-803
2
Cleared 510(K)
K
90
5212
IMMITTANCE METER, MODEL AE-105D/S
2
Cleared 510(K)
K
90
3066
AMPLAID 770 ADMITTANCE METER
2
Cleared 510(K)
K
89
4260
AE-105D DIAGNOSTIC TYMPANOMETER
2
Cleared 510(K)
K
89
5443
MODEL 210 IMPEDANCE SYSTEM
2
Cleared 510(K)
K
89
5783
IMPEDANCE ANALYZER MODELS MD-2, MD-P
2
Cleared 510(K)
K
89
0864
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
2
Cleared 510(K)
K
88
3293
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
2
Cleared 510(K)
K
88
3728
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
2
Cleared 510(K)
K
87
4354
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
2
Cleared 510(K)
K
87
1652
NEUROCOM PRESSURE TEST SYSTEM
2
Cleared 510(K)
K
86
3353
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
2
Cleared 510(K)
K
86
1516
WELCH ALLYN TYMPANOMETER
2
Cleared 510(K)
K
86
0262
TA-6C - PART NUMBER SLZ 7520
2
Cleared 510(K)
K
85
4043
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
2
Cleared 510(K)
K
85
3863
MODEL 310 IMPEDANCE SYSTEM
2
Cleared 510(K)
K
84
5049
Z0174, IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
85
0461
AUTOMATIC IMPEDANCE METER TA-7A
2
Cleared 510(K)
K
85
0007
ACOUSTIC OTOCOPE RECORDER
2
Cleared 510(K)
K
84
1568
IMPEDANCE/PURE TONE AUDIOMETER MA620
2
Cleared 510(K)
K
83
3045
CLINICAL TYMPANOMETER
2
Cleared 510(K)
K
83
1754
MA 610-IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
83
1755
MA600-IMPEDANCE AUDIOMETER
2
Cleared 510(K)
K
83
0139
ENDECO ACOUSTIC OTOSCOPE
2
Cleared 510(K)
K
82
3227
IMPEDANCE METER ON-1
2
Cleared 510(K)
K
82
2566
AURAL REFLEX INDICATOR
2
Cleared 510(K)
K
81
1509
AUTO-TYMPANIGRAPH (TA-5A)
2
Cleared 510(K)
K
80
2097
SELF-RECORDING ADMITTANCE METER 709
2
Cleared 510(K)
K
80
1293
ACOUSTIC IMPEDANCE METER, MODEL TA-4D
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
EN
/
subpart-b—diagnostic-devices
/
ETY
/
K994254
View Source
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K994254
510(k) Type
Traditional
Applicant
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2000
Days to Decision
88 days
Submission Type
Summary
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)
ETT
Cushion, Earphone (For Audiometric Testing)
ETY
Tester, Auditory Impedance
K
18
3201
Hearing Healthcare Pro
K
17
1038
Hearing Healthcare Pro
K
16
2210
touchTymp
K
16
1707
Madsen Zodiac
K
15
1616
AT235
K
15
1509
GSI TympStar Pro Middle Ear Analyzer
K
13
3013
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
K
12
1847
TITAN
K
08
3861
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
K
08
1841
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K
07
0312
EARCHECK ACOUSTIC REFLECTOMETER
K
03
3645
OTOFLEX 100 TYE 1012
K
03
1978
AMPLAID A756 SCREENING ADMITTANCE METER
K
02
2728
AUDIOTRAVELLER, MODEL AA222
K
00
0097
GSI 2000 MIDDLE EAR ANALYZER
K
99
4254
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K
99
1562
PASCAL MEDICAL AB MENIETT 20
K
99
2370
AMPLAID A724 AND A728
K
99
0652
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
K
99
0585
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
K
98
3832
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
K
98
3051
AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
K
98
3049
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
K
98
3046
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
K
97
4235
AMPLAID AM50
K
97
1859
EARCHECK
K
97
0685
EARCHECK PRO
K
95
5289
RACE CAR TYMPANOMETER
K
95
3161
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
K
94
2007
INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26
K
94
2008
INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER
K
93
0165
AE-207D TYMPANOMETER
K
93
0164
THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S
K
92
3072
HANDTYMP
K
92
3073
AUTOMATIC TYMPANOMETER
K
92
5585
GSI 38 AUTO TYMP
K
92
4934
AUTOMATIC IMPEDANCE METER AE-205
K
92
4933
AE-206 TYMPNOMWRWE(R) AUDIOMETER
K
91
0247
ZODIAC 901 MIDDLE-EAR ANALYZER
K
90
5704
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K
91
1095
GSI 37 AUTO TYMP
K
90
5213
MIDDLE EAR ANALYZER, MODEL AE-803
K
90
5212
IMMITTANCE METER, MODEL AE-105D/S
K
90
3066
AMPLAID 770 ADMITTANCE METER
K
89
4260
AE-105D DIAGNOSTIC TYMPANOMETER
K
89
5443
MODEL 210 IMPEDANCE SYSTEM
K
89
5783
IMPEDANCE ANALYZER MODELS MD-2, MD-P
K
89
0864
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
K
88
3293
STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
K
88
3728
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
K
87
4354
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
K
87
1652
NEUROCOM PRESSURE TEST SYSTEM
K
86
3353
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)
K
86
1516
WELCH ALLYN TYMPANOMETER
K
86
0262
TA-6C - PART NUMBER SLZ 7520
K
85
4043
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
K
85
3863
MODEL 310 IMPEDANCE SYSTEM
K
84
5049
Z0174, IMPEDANCE AUDIOMETER
K
85
0461
AUTOMATIC IMPEDANCE METER TA-7A
K
85
0007
ACOUSTIC OTOCOPE RECORDER
K
84
1568
IMPEDANCE/PURE TONE AUDIOMETER MA620
K
83
3045
CLINICAL TYMPANOMETER
K
83
1754
MA 610-IMPEDANCE AUDIOMETER
K
83
1755
MA600-IMPEDANCE AUDIOMETER
K
83
0139
ENDECO ACOUSTIC OTOSCOPE
K
82
3227
IMPEDANCE METER ON-1
K
82
2566
AURAL REFLEX INDICATOR
K
81
1509
AUTO-TYMPANIGRAPH (TA-5A)
K
80
2097
SELF-RECORDING ADMITTANCE METER 709
K
80
1293
ACOUSTIC IMPEDANCE METER, MODEL TA-4D
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
/
ETY
/
K994254
View Source
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K994254
510(k) Type
Traditional
Applicant
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2000
Days to Decision
88 days
Submission Type
Summary