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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
EWA
Set, Audiometer Calibration
1
Product Code
EWC
Chamber, Acoustic (For Audiometric Testing)
1
Product Code
EWO
Audiometer
2
Product Code
K
23
4095
OtoNova/OtoNova Pro
2
Cleared 510(K)
K
24
0430
Otoport Pro
2
Cleared 510(K)
K
23
1545
hearOAE
2
Cleared 510(K)
K
21
3345
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
2
Cleared 510(K)
K
19
1372
Lyra
2
Cleared 510(K)
K
18
0287
GSI Corti
2
Cleared 510(K)
K
17
3567
Sera
2
Cleared 510(K)
K
17
2403
GSI Novus
2
Cleared 510(K)
K
17
1506
Easyscreen
2
Cleared 510(K)
K
15
1025
iHearTest
2
Cleared 510(K)
K
15
0491
ER36 Series OAE Test System
2
Cleared 510(K)
K
14
1524
NEURO-AUDIO
2
Cleared 510(K)
K
14
3395
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
2
Cleared 510(K)
K
13
3012
SENTIERO
2
Cleared 510(K)
K
13
0795
TITAN
2
Cleared 510(K)
K
12
3624
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
2
Cleared 510(K)
K
12
2496
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
2
Cleared 510(K)
K
12
1512
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
2
Cleared 510(K)
K
11
2992
EARLOGIC OAE TESTER
2
Cleared 510(K)
K
11
2247
A BAER WITH ABAER I/O FUNCTION
2
Cleared 510(K)
K
11
1618
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
2
Cleared 510(K)
K
11
2733
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
2
Cleared 510(K)
K
10
3298
ACAM 5 AUDIOMETER SYSTEM
2
Cleared 510(K)
K
09
2089
CLARUJUST
2
Cleared 510(K)
K
09
2244
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
2
Cleared 510(K)
K
09
2111
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
2
Cleared 510(K)
K
09
0406
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
2
Cleared 510(K)
K
08
1234
GN OTOMETRICS INSERT EARPHONES
2
Cleared 510(K)
K
07
2033
OTODYNAMICS OTOPORT
2
Cleared 510(K)
K
07
0880
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
2
Cleared 510(K)
K
06
3452
MA 55 MAESTRO
2
Cleared 510(K)
K
07
0118
OTOGRAM, CA3350
2
Cleared 510(K)
K
06
3338
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
2
Cleared 510(K)
K
06
1744
COCHLEA-SCAN / COCHLEA-SCAN PLUS
2
Cleared 510(K)
K
06
0883
PILOT TEST OR DETECTIVE AUDIOMETERS
2
Cleared 510(K)
K
06
0885
MODEL MI 44 TYMPANOMETER
2
Cleared 510(K)
K
06
0539
DPOAE20 , ECLIPSE
2
Cleared 510(K)
K
05
3216
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
2
Cleared 510(K)
K
05
2562
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
2
Cleared 510(K)
K
04
3219
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
2
Cleared 510(K)
K
03
3108
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
2
Cleared 510(K)
K
03
1713
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
2
Cleared 510(K)
K
03
1986
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
2
Cleared 510(K)
K
03
1352
BIO-LOGIC INSERT EARPHONES
2
Cleared 510(K)
K
03
0016
TEOAE25
2
Cleared 510(K)
K
02
4205
AUDIOSCREENER OAE+ABR
2
Cleared 510(K)
K
02
3859
SMARTTROAE
2
Cleared 510(K)
K
02
1801
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
2
Cleared 510(K)
K
01
1135
GSI AUDERA
2
Cleared 510(K)
K
00
3364
VIVO 200 DPS VIVOSCAN
2
Cleared 510(K)
K
01
1114
ETYMOTIC RESEARCH ER-10D OAE PROBE
2
Cleared 510(K)
K
01
1181
ICS MEDICAL CHARTR OAE WITH TYMP
2
Cleared 510(K)
K
00
3913
HINT AUDIOMETER, OR HINT
2
Cleared 510(K)
K
01
0165
ERO SCAN OAE TEST SYSTEM
2
Cleared 510(K)
K
00
2200
CAPELLA
2
Cleared 510(K)
K
00
1058
AUDIOSCREENER OAE + ABR
2
Cleared 510(K)
K
99
4033
HORTMANN ECHOMASTER OAE ANALYZER
2
Cleared 510(K)
K
00
0184
AUDIOSCREENER OAE
2
Cleared 510(K)
K
98
4547
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
2
Cleared 510(K)
K
98
3915
AMPLAID A315 AND A319
2
Cleared 510(K)
K
98
3851
CAPELLA COCHLEAR EMISSIONS ANALYZER
2
Cleared 510(K)
K
98
3712
AMPLAID A311 SERIES
2
Cleared 510(K)
K
98
3352
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
2
Cleared 510(K)
K
98
3351
ILO292 DP ECHOPORT PLUS OAE SYSTEM
2
Cleared 510(K)
K
98
3350
ILO292 DP ECHOPORT PLUS OAE SYSTEM
2
Cleared 510(K)
K
98
3048
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
2
Cleared 510(K)
K
98
2878
EARSCAN 3
2
Cleared 510(K)
K
98
2723
MAICO MA42
2
Cleared 510(K)
K
98
2642
ECHO-SCREEN
2
Cleared 510(K)
K
98
2566
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
2
Cleared 510(K)
K
98
2441
CCA-220
2
Cleared 510(K)
K
98
2249
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
2
Cleared 510(K)
K
98
1511
OTO WIZZARD
2
Cleared 510(K)
K
98
1439
CCA-200
2
Cleared 510(K)
K
98
1460
CUB DIS II DPOAE MEASUREMENT SYSTEM
2
Cleared 510(K)
K
98
1327
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
2
Cleared 510(K)
K
98
1142
MAICO MA53
2
Cleared 510(K)
K
98
0505
HORTMANN AMDIS-OAE OAE ANALYZER
2
Cleared 510(K)
K
98
0533
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
2
Cleared 510(K)
K
97
3377
SIBELMED AC50D
2
Cleared 510(K)
K
97
4237
GSI 70 AUDIOPATH SCREENER
2
Cleared 510(K)
K
97
4076
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
2
Cleared 510(K)
K
97
3320
ARTICULATE FITTING SYSTEM
2
Cleared 510(K)
K
97
2862
AMPLAID 171S
2
Cleared 510(K)
K
97
2221
K 15 AUDIOMETER
2
Cleared 510(K)
K
97
1747
AMPLAID 460
2
Cleared 510(K)
K
97
1080
MAICO MA52
2
Cleared 510(K)
K
96
4132
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
2
Cleared 510(K)
K
97
0279
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
2
Cleared 510(K)
K
97
0555
IL0292 DP ECHOPORT
2
Cleared 510(K)
K
96
4426
SMARTOAE
2
Cleared 510(K)
K
96
4340
PORTAREM-3000, PFS-6000
2
Cleared 510(K)
K
96
2995
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
2
Cleared 510(K)
K
96
3681
CCA-100 (MODIFIED)
2
Cleared 510(K)
K
96
2275
MAICO MA25 SERIES II WITH SPEECH
2
Cleared 510(K)
K
96
2012
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
2
Cleared 510(K)
K
96
1447
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
2
Cleared 510(K)
K
95
3814
OTOSCAPE
2
Cleared 510(K)
K
95
3884
PROPHET
2
Cleared 510(K)
K
95
3684
GSI 61 CLINICAL AUDIOMETER
2
Cleared 510(K)
K
94
3616
BELTONE PERSONAL HEARING SCREENER
2
Cleared 510(K)
K
95
1759
GSI 65 COMPUTERIZED AUDIOMETER
2
Cleared 510(K)
K
94
3215
DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
2
Cleared 510(K)
K
95
1527
THE PILOT AUDIOMETER
2
Cleared 510(K)
K
94
5199
RH2000 REAL EAR MEASUREMENT SYSTEM
2
Cleared 510(K)
K
95
0888
SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY
2
Cleared 510(K)
K
94
5689
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)
2
Cleared 510(K)
K
94
5032
VOYAGER 522
2
Cleared 510(K)
K
94
4735
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
2
Cleared 510(K)
K
94
1920
INTERACOUSTICS CLINICAL AUDIOMETER
2
Cleared 510(K)
K
94
2716
AUDIO EXPERT AUDIOMETER
2
Cleared 510(K)
K
94
3066
INTERACOUSTICS COMPUTER AUDIOMETER BA 20
2
Cleared 510(K)
K
93
1322
KS 5 - CLINICAL AUDIOMETER
2
Cleared 510(K)
K
94
3065
INTERACOUSTICS CLINICAL AUDIOMETER
2
Cleared 510(K)
K
94
0216
BELTONE SERIES 100 AUDIOMETERS
2
Cleared 510(K)
K
93
5719
DAIL A HEARING SCREENING TEST
2
Cleared 510(K)
K
94
2006
INTERACOUSTICS DIAGNOSTIC AUDIOMETER
2
Cleared 510(K)
K
93
4715
MODEL 222 CLINICAL AUDIOMETER
2
Cleared 510(K)
K
94
0999
PRODIGIT 2000
2
Cleared 510(K)
K
93
1325
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
2
Cleared 510(K)
K
93
5348
ODYSSEY CLINICAL AUDIOMETER
2
Cleared 510(K)
K
93
4658
GSI 60 DPOAE SYSTEM
2
Cleared 510(K)
K
93
3097
SOUND SELECTOR FULL-SERVICE AUDIOMETER
2
Cleared 510(K)
K
93
4343
GLASER RT60, RT80, RT150 AUDIOMETER
2
Cleared 510(K)
K
93
3220
SELECTOR SL 01
2
Cleared 510(K)
K
93
1324
ORBITER 922 CLINICAL AUDIOMETER
2
Cleared 510(K)
K
93
3222
AUDIOMETER DA 323
2
Cleared 510(K)
K
93
0553
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
2
Cleared 510(K)
K
93
0112
MAICO MA790 AUDIOMETER
2
Cleared 510(K)
K
92
6439
MA25 - PORTABLE AUDIOMETER, MODIFICATION
2
Cleared 510(K)
K
93
0260
ACOUSTIC ANALYZER AA30
2
Cleared 510(K)
K
93
0003
TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
2
Cleared 510(K)
K
92
6336
AUDIOSCAN
2
Cleared 510(K)
K
92
4543
DSP SCREENING AUDIOMETER
2
Cleared 510(K)
K
92
3007
AT-2
2
Cleared 510(K)
K
92
2383
THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO
2
Cleared 510(K)
K
92
2746
ST 20 PORTABLE AUDIOMETER
2
Cleared 510(K)
K
92
3074
DANPLEX SCREENING AUDIOMETER
2
Cleared 510(K)
K
92
3013
ACOUSTIC APPRAISE CD-3
2
Cleared 510(K)
K
92
1085
PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)
2
Cleared 510(K)
K
91
5323
THE BELTONE AUDIO SCOUT
2
Cleared 510(K)
K
91
4232
ASRA, SCREENING AUDIOMETER
2
Cleared 510(K)
K
91
3356
THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
2
Cleared 510(K)
K
91
3589
EARSCAN DSP-1 PURE TONE AUDIOMETER
2
Cleared 510(K)
K
91
3276
MICROTEK MEDICAL'S SOUND STIKS
2
Cleared 510(K)
K
91
1689
MODEL 330 SCREENING AUDIOMETER
2
Cleared 510(K)
K
91
3221
TYPE FA10 AUDIOMETER
2
Cleared 510(K)
K
90
4622
HEARING CHECKER(TM), DESKTOP MODEL
2
Cleared 510(K)
K
91
2669
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
2
Cleared 510(K)
K
91
1368
MAICO MA800 AUDIOMETER
2
Cleared 510(K)
K
90
0197
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
2
Cleared 510(K)
K
90
4544
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
2
Cleared 510(K)
K
90
4270
BIOLINK AUDIOMETER SOFTWARE ACCESSORY
2
Cleared 510(K)
K
90
3143
OTOSCREENER-I AND OTO-SCREEN-I-P
2
Cleared 510(K)
K
90
2068
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
2
Cleared 510(K)
K
90
2540
GSI 17 SCREENING AUDIOMETER
2
Cleared 510(K)
K
89
4484
AUDIOTESTER SCREENING AUDIOMETER
2
Cleared 510(K)
K
90
0096
INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
2
Cleared 510(K)
K
89
6710
MIDIMATE 622
2
Cleared 510(K)
K
89
6401
MICROMATE 304
2
Cleared 510(K)
K
89
6909
MD5 AUTOMATIC AUDIOMETER
2
Cleared 510(K)
K
89
5310
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
2
Cleared 510(K)
K
89
5200
MODEL EB-22 NOISE STIK
2
Cleared 510(K)
K
89
5785
AUDIOMETER MODEL MD-4, MD-4P
2
Cleared 510(K)
K
89
4748
IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
2
Cleared 510(K)
K
89
5784
IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
2
Cleared 510(K)
K
89
1988
AMPLAID A308 CLINICAL AUDIOMETER
2
Cleared 510(K)
K
89
0993
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
2
Cleared 510(K)
K
88
3505
BIOMETER AUDIOMETER
2
Cleared 510(K)
K
89
1373
TRACOR RA500 AUDIOMETER
2
Cleared 510(K)
K
89
0124
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
2
Cleared 510(K)
K
89
0842
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
2
Cleared 510(K)
K
89
0497
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
2
Cleared 510(K)
K
88
4218
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
2
Cleared 510(K)
K
88
4044
AUDIOMETER DIGITAL HEARING SYSTEM
2
Cleared 510(K)
K
88
3169
OTOMETER PORTABLE SCREENING AUDIOMETER
2
Cleared 510(K)
K
88
3478
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
2
Cleared 510(K)
K
88
1760
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
2
Cleared 510(K)
K
88
0059
AMPLAID 309 CLINICAL AUDIOMETER
2
Cleared 510(K)
K
87
5360
THE BELTONE 2000 AUDIOMETER
2
Cleared 510(K)
K
87
4516
MODEL V4 AUDIOMETER
2
Cleared 510(K)
K
87
2042
PLAYTONE AUDIOMETER
2
Cleared 510(K)
K
86
3979
MICROSCREEN I HEARING TESTER
2
Cleared 510(K)
K
86
3984
MODEL 320 TWO CHANNEL AUDIOMETER
2
Cleared 510(K)
K
86
2592
PHOENIX SYSTEM SEVEN.
2
Cleared 510(K)
K
86
2770
AUDIOMETER/MASTER HEARING AID MF6
2
Cleared 510(K)
K
85
4835
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
2
Cleared 510(K)
K
85
4534
DIGITAL SCREENING AUDIOMETER DSA6214
2
Cleared 510(K)
K
85
4125
CRAIGWELL AID FITTING SYSTEM AFS
2
Cleared 510(K)
K
85
3919
MA25 PORTABLE AUDIOMETER
2
Cleared 510(K)
K
85
3245
TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
2
Cleared 510(K)
K
85
1392
TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200
2
Cleared 510(K)
K
85
1015
TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER
2
Cleared 510(K)
K
84
5050
UP800 A UNIVERSAL PRINTER
2
Cleared 510(K)
K
84
4069
TA-201 CLINICAL AUDIOMETER
2
Cleared 510(K)
K
84
3618
AUDIOMETER
2
Cleared 510(K)
K
84
1567
AUDIOMETER MA728
2
Cleared 510(K)
K
84
1167
DEMLAR SYS I COMPUTER BASED AUDIOMETER
2
Cleared 510(K)
K
83
3883
DIGITAL AUDIOMETER/HEARING AID 3100
2
Cleared 510(K)
K
83
1431
AUDIOMETER MODEL-500
2
Cleared 510(K)
K
82
2335
AUDIT
2
Cleared 510(K)
K
82
3554
ACOH WELLNESS TESTER
2
Cleared 510(K)
K
82
2745
THE SCREENING TYMPANOMETER
2
Cleared 510(K)
K
82
2414
TRACOR RA400 AUDIOMETER
2
Cleared 510(K)
K
82
0715
MIDDLE EAR ANALYZER (IMPEDANCE AUDIO
2
Cleared 510(K)
K
81
2529
EARSCAN
2
Cleared 510(K)
K
81
1727
PORTABLE AUDIOMETERS
2
Cleared 510(K)
K
81
0583
AUDIOMETER
2
Cleared 510(K)
K
81
0537
AUTOMATIC SCREENING AUDIOMETER
2
Cleared 510(K)
K
80
3072
HIGH FREQUENCY AUDIOMETER DELMAR #20-K
2
Cleared 510(K)
K
80
2963
101, 151, 161 PORTABLE AUDIOMETERS
2
Cleared 510(K)
K
80
2560
TINNITUS RESEARCH AUDIOMETER
2
Cleared 510(K)
K
80
2350
ATTENU-CHEK
2
Cleared 510(K)
K
80
2207
RION DIAGNOSTIC AUDIOMETER
2
Cleared 510(K)
K
80
1325
CLINICAL AUDIOMETER MODEL TA-200
2
Cleared 510(K)
K
79
1467
TA-10 PORTABLE SCREENING AUDIOMETER
2
Cleared 510(K)
K
79
0878
SCREENING AUDIOMETER, HIGH FREQUENCY
2
Cleared 510(K)
K
79
1170
MIS AURAL ACOUSTIC SCREENER
2
Cleared 510(K)
K
79
0903
TRACOR MODEL RA-411 MICROPROCESSOR
2
Cleared 510(K)
K
79
0846
MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)
2
Cleared 510(K)
K
79
0609
AUDIOMETER
2
Cleared 510(K)
K
78
1474
PREAMPLIFIER MODELS 8101PI & 8102PI
2
Cleared 510(K)
K
78
0749
SPEECH AUDIOMETER RA 226
2
Cleared 510(K)
K
78
0450
TRACOR RA 410 AUDIOMETER
2
Cleared 510(K)
K
78
0382
AUDIOMETER, PORTABLE, AIR CONDUCTION
2
Cleared 510(K)
K
78
0269
COMPUTER AUDIOMETER - MA25
2
Cleared 510(K)
K
78
0270
COMPUTER AUDIOMETER - MA26
2
Cleared 510(K)
K
78
0150
NEONATAL SCREENING AUDIOMETER
2
Cleared 510(K)
K
77
2169
AUDIOMETER, RECORDING, AUTOMATIC
2
Cleared 510(K)
K
77
0823
AUDIOMETRIC TESTING SYS., SERIES 500
2
Cleared 510(K)
K
77
0616
AUDIOMETER, MA29, PURE TONE AIR CONDUCT.
2
Cleared 510(K)
K
77
0618
AUDIOMETER, MA31
2
Cleared 510(K)
K
77
0617
AUDIOMETER, MA30, AIR & BONE CONDUCTION
2
Cleared 510(K)
K
77
0553
AUDIOMETER, DIAG., ADVANCED, MA-22
2
Cleared 510(K)
K
76
0859
TRACOR MODEL RA 208 COMPLIANCE AUDIOM
2
Cleared 510(K)
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
/
EWO
/
K112247
View Source
A BAER WITH ABAER I/O FUNCTION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112247
510(k) Type
Traditional
Applicant
NATUS MEDICAL INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/2/2012
Days to Decision
242 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
EWA
Set, Audiometer Calibration
EWC
Chamber, Acoustic (For Audiometric Testing)
EWO
Audiometer
K
23
4095
OtoNova/OtoNova Pro
K
24
0430
Otoport Pro
K
23
1545
hearOAE
K
21
3345
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
K
19
1372
Lyra
K
18
0287
GSI Corti
K
17
3567
Sera
K
17
2403
GSI Novus
K
17
1506
Easyscreen
K
15
1025
iHearTest
K
15
0491
ER36 Series OAE Test System
K
14
1524
NEURO-AUDIO
K
14
3395
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
K
13
3012
SENTIERO
K
13
0795
TITAN
K
12
3624
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
K
12
2496
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K
12
1512
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K
11
2992
EARLOGIC OAE TESTER
K
11
2247
A BAER WITH ABAER I/O FUNCTION
K
11
1618
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
K
11
2733
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K
10
3298
ACAM 5 AUDIOMETER SYSTEM
K
09
2089
CLARUJUST
K
09
2244
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
K
09
2111
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
K
09
0406
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
K
08
1234
GN OTOMETRICS INSERT EARPHONES
K
07
2033
OTODYNAMICS OTOPORT
K
07
0880
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K
06
3452
MA 55 MAESTRO
K
07
0118
OTOGRAM, CA3350
K
06
3338
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
K
06
1744
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K
06
0883
PILOT TEST OR DETECTIVE AUDIOMETERS
K
06
0885
MODEL MI 44 TYMPANOMETER
K
06
0539
DPOAE20 , ECLIPSE
K
05
3216
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
K
05
2562
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
K
04
3219
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
K
03
3108
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
K
03
1713
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
K
03
1986
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
K
03
1352
BIO-LOGIC INSERT EARPHONES
K
03
0016
TEOAE25
K
02
4205
AUDIOSCREENER OAE+ABR
K
02
3859
SMARTTROAE
K
02
1801
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K
01
1135
GSI AUDERA
K
00
3364
VIVO 200 DPS VIVOSCAN
K
01
1114
ETYMOTIC RESEARCH ER-10D OAE PROBE
K
01
1181
ICS MEDICAL CHARTR OAE WITH TYMP
K
00
3913
HINT AUDIOMETER, OR HINT
K
01
0165
ERO SCAN OAE TEST SYSTEM
K
00
2200
CAPELLA
K
00
1058
AUDIOSCREENER OAE + ABR
K
99
4033
HORTMANN ECHOMASTER OAE ANALYZER
K
00
0184
AUDIOSCREENER OAE
K
98
4547
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K
98
3915
AMPLAID A315 AND A319
K
98
3851
CAPELLA COCHLEAR EMISSIONS ANALYZER
K
98
3712
AMPLAID A311 SERIES
K
98
3352
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
K
98
3351
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K
98
3350
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K
98
3048
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
K
98
2878
EARSCAN 3
K
98
2723
MAICO MA42
K
98
2642
ECHO-SCREEN
K
98
2566
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)
K
98
2441
CCA-220
K
98
2249
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
K
98
1511
OTO WIZZARD
K
98
1439
CCA-200
K
98
1460
CUB DIS II DPOAE MEASUREMENT SYSTEM
K
98
1327
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
K
98
1142
MAICO MA53
K
98
0505
HORTMANN AMDIS-OAE OAE ANALYZER
K
98
0533
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
K
97
3377
SIBELMED AC50D
K
97
4237
GSI 70 AUDIOPATH SCREENER
K
97
4076
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K
97
3320
ARTICULATE FITTING SYSTEM
K
97
2862
AMPLAID 171S
K
97
2221
K 15 AUDIOMETER
K
97
1747
AMPLAID 460
K
97
1080
MAICO MA52
K
96
4132
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K
97
0279
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
K
97
0555
IL0292 DP ECHOPORT
K
96
4426
SMARTOAE
K
96
4340
PORTAREM-3000, PFS-6000
K
96
2995
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K
96
3681
CCA-100 (MODIFIED)
K
96
2275
MAICO MA25 SERIES II WITH SPEECH
K
96
2012
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
K
96
1447
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
K
95
3814
OTOSCAPE
K
95
3884
PROPHET
K
95
3684
GSI 61 CLINICAL AUDIOMETER
K
94
3616
BELTONE PERSONAL HEARING SCREENER
K
95
1759
GSI 65 COMPUTERIZED AUDIOMETER
K
94
3215
DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER
K
95
1527
THE PILOT AUDIOMETER
K
94
5199
RH2000 REAL EAR MEASUREMENT SYSTEM
K
95
0888
SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY
K
94
5689
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)
K
94
5032
VOYAGER 522
K
94
4735
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
K
94
1920
INTERACOUSTICS CLINICAL AUDIOMETER
K
94
2716
AUDIO EXPERT AUDIOMETER
K
94
3066
INTERACOUSTICS COMPUTER AUDIOMETER BA 20
K
93
1322
KS 5 - CLINICAL AUDIOMETER
K
94
3065
INTERACOUSTICS CLINICAL AUDIOMETER
K
94
0216
BELTONE SERIES 100 AUDIOMETERS
K
93
5719
DAIL A HEARING SCREENING TEST
K
94
2006
INTERACOUSTICS DIAGNOSTIC AUDIOMETER
K
93
4715
MODEL 222 CLINICAL AUDIOMETER
K
94
0999
PRODIGIT 2000
K
93
1325
OTOACOUSTIC EMISSIONS UNIT CELESTA 503
K
93
5348
ODYSSEY CLINICAL AUDIOMETER
K
93
4658
GSI 60 DPOAE SYSTEM
K
93
3097
SOUND SELECTOR FULL-SERVICE AUDIOMETER
K
93
4343
GLASER RT60, RT80, RT150 AUDIOMETER
K
93
3220
SELECTOR SL 01
K
93
1324
ORBITER 922 CLINICAL AUDIOMETER
K
93
3222
AUDIOMETER DA 323
K
93
0553
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
K
93
0112
MAICO MA790 AUDIOMETER
K
92
6439
MA25 - PORTABLE AUDIOMETER, MODIFICATION
K
93
0260
ACOUSTIC ANALYZER AA30
K
93
0003
TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
K
92
6336
AUDIOSCAN
K
92
4543
DSP SCREENING AUDIOMETER
K
92
3007
AT-2
K
92
2383
THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO
K
92
2746
ST 20 PORTABLE AUDIOMETER
K
92
3074
DANPLEX SCREENING AUDIOMETER
K
92
3013
ACOUSTIC APPRAISE CD-3
K
92
1085
PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)
K
91
5323
THE BELTONE AUDIO SCOUT
K
91
4232
ASRA, SCREENING AUDIOMETER
K
91
3356
THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
K
91
3589
EARSCAN DSP-1 PURE TONE AUDIOMETER
K
91
3276
MICROTEK MEDICAL'S SOUND STIKS
K
91
1689
MODEL 330 SCREENING AUDIOMETER
K
91
3221
TYPE FA10 AUDIOMETER
K
90
4622
HEARING CHECKER(TM), DESKTOP MODEL
K
91
2669
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K
91
1368
MAICO MA800 AUDIOMETER
K
90
0197
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
K
90
4544
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K
90
4270
BIOLINK AUDIOMETER SOFTWARE ACCESSORY
K
90
3143
OTOSCREENER-I AND OTO-SCREEN-I-P
K
90
2068
HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER
K
90
2540
GSI 17 SCREENING AUDIOMETER
K
89
4484
AUDIOTESTER SCREENING AUDIOMETER
K
90
0096
INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
K
89
6710
MIDIMATE 622
K
89
6401
MICROMATE 304
K
89
6909
MD5 AUTOMATIC AUDIOMETER
K
89
5310
AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7
K
89
5200
MODEL EB-22 NOISE STIK
K
89
5785
AUDIOMETER MODEL MD-4, MD-4P
K
89
4748
IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
K
89
5784
IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
K
89
1988
AMPLAID A308 CLINICAL AUDIOMETER
K
89
0993
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K
88
3505
BIOMETER AUDIOMETER
K
89
1373
TRACOR RA500 AUDIOMETER
K
89
0124
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
K
89
0842
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K
89
0497
MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER
K
88
4218
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K
88
4044
AUDIOMETER DIGITAL HEARING SYSTEM
K
88
3169
OTOMETER PORTABLE SCREENING AUDIOMETER
K
88
3478
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K
88
1760
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K
88
0059
AMPLAID 309 CLINICAL AUDIOMETER
K
87
5360
THE BELTONE 2000 AUDIOMETER
K
87
4516
MODEL V4 AUDIOMETER
K
87
2042
PLAYTONE AUDIOMETER
K
86
3979
MICROSCREEN I HEARING TESTER
K
86
3984
MODEL 320 TWO CHANNEL AUDIOMETER
K
86
2592
PHOENIX SYSTEM SEVEN.
K
86
2770
AUDIOMETER/MASTER HEARING AID MF6
K
85
4835
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K
85
4534
DIGITAL SCREENING AUDIOMETER DSA6214
K
85
4125
CRAIGWELL AID FITTING SYSTEM AFS
K
85
3919
MA25 PORTABLE AUDIOMETER
K
85
3245
TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
K
85
1392
TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200
K
85
1015
TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER
K
84
5050
UP800 A UNIVERSAL PRINTER
K
84
4069
TA-201 CLINICAL AUDIOMETER
K
84
3618
AUDIOMETER
K
84
1567
AUDIOMETER MA728
K
84
1167
DEMLAR SYS I COMPUTER BASED AUDIOMETER
K
83
3883
DIGITAL AUDIOMETER/HEARING AID 3100
K
83
1431
AUDIOMETER MODEL-500
K
82
2335
AUDIT
K
82
3554
ACOH WELLNESS TESTER
K
82
2745
THE SCREENING TYMPANOMETER
K
82
2414
TRACOR RA400 AUDIOMETER
K
82
0715
MIDDLE EAR ANALYZER (IMPEDANCE AUDIO
K
81
2529
EARSCAN
K
81
1727
PORTABLE AUDIOMETERS
K
81
0583
AUDIOMETER
K
81
0537
AUTOMATIC SCREENING AUDIOMETER
K
80
3072
HIGH FREQUENCY AUDIOMETER DELMAR #20-K
K
80
2963
101, 151, 161 PORTABLE AUDIOMETERS
K
80
2560
TINNITUS RESEARCH AUDIOMETER
K
80
2350
ATTENU-CHEK
K
80
2207
RION DIAGNOSTIC AUDIOMETER
K
80
1325
CLINICAL AUDIOMETER MODEL TA-200
K
79
1467
TA-10 PORTABLE SCREENING AUDIOMETER
K
79
0878
SCREENING AUDIOMETER, HIGH FREQUENCY
K
79
1170
MIS AURAL ACOUSTIC SCREENER
K
79
0903
TRACOR MODEL RA-411 MICROPROCESSOR
K
79
0846
MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)
K
79
0609
AUDIOMETER
K
78
1474
PREAMPLIFIER MODELS 8101PI & 8102PI
K
78
0749
SPEECH AUDIOMETER RA 226
K
78
0450
TRACOR RA 410 AUDIOMETER
K
78
0382
AUDIOMETER, PORTABLE, AIR CONDUCTION
K
78
0269
COMPUTER AUDIOMETER - MA25
K
78
0270
COMPUTER AUDIOMETER - MA26
K
78
0150
NEONATAL SCREENING AUDIOMETER
K
77
2169
AUDIOMETER, RECORDING, AUTOMATIC
K
77
0823
AUDIOMETRIC TESTING SYS., SERIES 500
K
77
0616
AUDIOMETER, MA29, PURE TONE AIR CONDUCT.
K
77
0618
AUDIOMETER, MA31
K
77
0617
AUDIOMETER, MA30, AIR & BONE CONDUCTION
K
77
0553
AUDIOMETER, DIAG., ADVANCED, MA-22
K
76
0859
TRACOR MODEL RA 208 COMPLIANCE AUDIOM
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
/
EWO
/
K112247
View Source
A BAER WITH ABAER I/O FUNCTION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112247
510(k) Type
Traditional
Applicant
NATUS MEDICAL INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/2/2012
Days to Decision
242 days
Submission Type
Summary