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
Subpart D—Prosthetic Devices
CFR Sub-Part
EPF
Hearing Aid, Group And Auditory Trainer
2
Product Code
NEA
Cement, Ear, Nose And Throat
2
Product Code
ESD
Hearing Aid, Air Conduction
1
Product Code
ESE
Larynx, Artificial (Battery-Powered)
1
Product Code
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
2
Product Code
ESX
Tack, Sacculotomy (Cody Tack)
2
Product Code
ESZ
Tube, Shunt, Endolymphatic
2
Product Code
ETA
Replacement, Ossicular Prosthesis, Total
2
Product Code
ETB
Prosthesis, Partial Ossicular Replacement
2
Product Code
ETC
Mold, Middle-Ear
2
Product Code
ETD
Tube, Tympanostomy
2
Product Code
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
2
Product Code
K
12
2028
AURICAL HIT
2
Cleared 510(K)
K
11
3831
PRIMUS HEARING INSTRUMENT TEST UNIT
2
Cleared 510(K)
K
11
0286
GN OTOMETRICS TYPE 1053 FREEFIT
2
Cleared 510(K)
K
09
3006
FONIX ,MODEL 8000
2
Cleared 510(K)
K
07
1462
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
2
Cleared 510(K)
K
06
1104
SPEECHLINK 100 TYPE 1053
2
Cleared 510(K)
K
05
0496
REM440
2
Cleared 510(K)
K
04
1853
OTOGRAM
2
Cleared 510(K)
K
02
2510
FONIX, MODEL 7000
2
Cleared 510(K)
K
01
2306
AUDIOSCAN VERIFIT, MODEL VF-1
2
Cleared 510(K)
K
98
0377
FONIX FP35 HEARING AID ANALYZER
2
Cleared 510(K)
K
97
0324
GSI SA60 DPOAE SYSTEM
2
Cleared 510(K)
K
96
0229
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
2
Cleared 510(K)
K
95
2098
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
2
Cleared 510(K)
K
94
3459
DESKREM-1000
2
Cleared 510(K)
K
94
3460
PORTAREM 2000
2
Cleared 510(K)
K
94
3607
INTERACOUSTICS HEARING AID ANALYZER MS 40
2
Cleared 510(K)
K
94
1848
INTERACOUSTICS. HEARING AID ANALYZER
2
Cleared 510(K)
K
93
4342
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
2
Cleared 510(K)
K
93
5400
FONIX 3500 HEARING AID ANALYZER
2
Cleared 510(K)
K
90
2244
RASTRONICS CCI 8
2
Cleared 510(K)
K
90
2252
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
2
Cleared 510(K)
K
89
6996
CAS (COMPUTERIZED ANALYZER SYSTEM)
2
Cleared 510(K)
K
89
6477
NICOLET REAL EAR ANALYZER
2
Cleared 510(K)
K
89
5383
TYPE FP40 DIGITAL HEARING AID ANALYZER
2
Cleared 510(K)
K
89
6301
MODEL 340 PROBE MIC SYSTEM
2
Cleared 510(K)
K
88
4371
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
2
Cleared 510(K)
K
88
4372
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
2
Cleared 510(K)
K
88
4046
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
2
Cleared 510(K)
K
87
2633
MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM
2
Cleared 510(K)
K
87
2242
TYPE 6400 REAL EAR HEARING AID ANALYZER
2
Cleared 510(K)
K
87
0337
AUDIOMETER
2
Cleared 510(K)
K
87
0229
HEARING AID TEST SYSTEM MODEL HAT 1000
2
Cleared 510(K)
K
86
2026
HA-2000 REAL EAR SPECTROSCOPE
2
Cleared 510(K)
K
86
2162
PHONIC EAR, MODEL PE 1800
2
Cleared 510(K)
K
86
2086
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
2
Cleared 510(K)
K
86
1857
PHONIC EAR
2
Cleared 510(K)
K
86
1571
TYPE 6500 HEARING AID ANALYZER
2
Cleared 510(K)
K
86
1113
ER-7C CLINICAL PROBE MICROPHONE
2
Cleared 510(K)
K
85
4535
INSERTION GAIN OPTIMIZER IGO-1000
2
Cleared 510(K)
K
85
3271
HEARING AID ANALYSIS SYSTEM
2
Cleared 510(K)
K
85
3320
FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10
2
Cleared 510(K)
K
85
0918
TYPE FP30 DIGITAL HEARING AID ANALYZER
2
Cleared 510(K)
K
84
4275
STARKET MODEL HMS
2
Cleared 510(K)
K
82
1908
STARKEY MODEL HAL-1
2
Cleared 510(K)
K
80
1905
FONIX TYPE 5100 HEARING AID ANALYZER
2
Cleared 510(K)
EWL
Prosthesis, Laryngeal (Taub)
2
Product Code
FWN
Prosthesis, Larynx (Stents And Keels)
2
Product Code
JAZ
Prosthesis, Facial, Mandibular Implant
2
Product Code
JOF
Polymer, Ent Synthetic, Porous Polyethylene
2
Product Code
JXS
Block, Cutting, Ent, Sterile
1
Product Code
JXT
Crimper, Wire, Ent, Sterile
1
Product Code
JXW
Die, Wire Bending, Ent, Sterile
1
Product Code
JXX
Forceps, Wire Closure, Ent, Sterile
1
Product Code
JXY
Jig, Piston Cutting, Ent, Sterile
1
Product Code
JXZ
Punch, Gelfoam, Sterile
1
Product Code
JYA
Scissors, Wire Cutting, Ent, Sterile
1
Product Code
JYB
Vise, Ossicular Finger, Sterile
1
Product Code
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
2
Product Code
KHL
Hearing Aid, Master
2
Product Code
KLW
Masker, Tinnitus
2
Product Code
KLZ
Tube, Shunt, Endolymphatic With Valve
2
Product Code
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
2
Product Code
LBL
Tube, Tympanostomy, Porous Polyethylene
2
Product Code
LBM
Porous Polyethylene Ossicular Replacement
2
Product Code
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
2
Product Code
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
2
Product Code
LDG
Kit, Earmold, Impression
1
Product Code
LRB
Face Plate Hearing Aid
1
Product Code
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
1
Product Code
LWF
Dilator, Nasal
1
Product Code
LXB
Hearing Aid, Bone Conduction
2
Product Code
LZI
Device, Assistive Listening
2
Product Code
MAH
Hearing Aid, Bone Conduction, Implanted
2
Product Code
MCK
Device, Voice Amplification
2
Product Code
MIX
System, Vocal Cord Medialization
2
Product Code
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
2
Product Code
NIX
Hearing Aid, Air Conduction, Transcutaneous System
2
Product Code
NNN
Crimper, Wire, Ent, Non-Sterile
1
Product Code
NNO
Jig, Piston Cutting, Ent, Non-Sterile
1
Product Code
NNP
Die, Wire Bending, Ent, Non-Sterile
1
Product Code
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
1
Product Code
NNR
Block, Cutting, Ent, Non-Sterile
1
Product Code
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
1
Product Code
NNT
Punch, Gelfoam, Non-Sterile
1
Product Code
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
1
Product Code
NNV
Vise, Ossicular Finger, Non-Sterile
1
Product Code
OGS
Myringotomy Procedure Kit
2
Product Code
OSM
Hearing Aid, Air Conduction With Wireless Technology
2
Product Code
PFO
Active Implantable Bone Conduction Hearing System
2
Product Code
PLK
Tympanic Membrane Direct Contact Hearing Aid
2
Product Code
QDD
Self-Fitting Air-Conduction Hearing Aid
2
Product Code
QUF
Hearing Aid, Air-Conduction, Over The Counter
1
Product Code
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
2
Product Code
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
2
Product Code
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-d—prosthetic-devices
/
ETW
/
K801905
View Source
FONIX TYPE 5100 HEARING AID ANALYZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801905
510(k) Type
Traditional
Applicant
FRYE ELECTRONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/1980
Days to Decision
16 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
EPF
Hearing Aid, Group And Auditory Trainer
NEA
Cement, Ear, Nose And Throat
ESD
Hearing Aid, Air Conduction
ESE
Larynx, Artificial (Battery-Powered)
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
ESX
Tack, Sacculotomy (Cody Tack)
ESZ
Tube, Shunt, Endolymphatic
ETA
Replacement, Ossicular Prosthesis, Total
ETB
Prosthesis, Partial Ossicular Replacement
ETC
Mold, Middle-Ear
ETD
Tube, Tympanostomy
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
K
12
2028
AURICAL HIT
K
11
3831
PRIMUS HEARING INSTRUMENT TEST UNIT
K
11
0286
GN OTOMETRICS TYPE 1053 FREEFIT
K
09
3006
FONIX ,MODEL 8000
K
07
1462
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K
06
1104
SPEECHLINK 100 TYPE 1053
K
05
0496
REM440
K
04
1853
OTOGRAM
K
02
2510
FONIX, MODEL 7000
K
01
2306
AUDIOSCAN VERIFIT, MODEL VF-1
K
98
0377
FONIX FP35 HEARING AID ANALYZER
K
97
0324
GSI SA60 DPOAE SYSTEM
K
96
0229
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
K
95
2098
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
K
94
3459
DESKREM-1000
K
94
3460
PORTAREM 2000
K
94
3607
INTERACOUSTICS HEARING AID ANALYZER MS 40
K
94
1848
INTERACOUSTICS. HEARING AID ANALYZER
K
93
4342
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
K
93
5400
FONIX 3500 HEARING AID ANALYZER
K
90
2244
RASTRONICS CCI 8
K
90
2252
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
K
89
6996
CAS (COMPUTERIZED ANALYZER SYSTEM)
K
89
6477
NICOLET REAL EAR ANALYZER
K
89
5383
TYPE FP40 DIGITAL HEARING AID ANALYZER
K
89
6301
MODEL 340 PROBE MIC SYSTEM
K
88
4371
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K
88
4372
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K
88
4046
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
K
87
2633
MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM
K
87
2242
TYPE 6400 REAL EAR HEARING AID ANALYZER
K
87
0337
AUDIOMETER
K
87
0229
HEARING AID TEST SYSTEM MODEL HAT 1000
K
86
2026
HA-2000 REAL EAR SPECTROSCOPE
K
86
2162
PHONIC EAR, MODEL PE 1800
K
86
2086
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
K
86
1857
PHONIC EAR
K
86
1571
TYPE 6500 HEARING AID ANALYZER
K
86
1113
ER-7C CLINICAL PROBE MICROPHONE
K
85
4535
INSERTION GAIN OPTIMIZER IGO-1000
K
85
3271
HEARING AID ANALYSIS SYSTEM
K
85
3320
FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10
K
85
0918
TYPE FP30 DIGITAL HEARING AID ANALYZER
K
84
4275
STARKET MODEL HMS
K
82
1908
STARKEY MODEL HAL-1
K
80
1905
FONIX TYPE 5100 HEARING AID ANALYZER
EWL
Prosthesis, Laryngeal (Taub)
FWN
Prosthesis, Larynx (Stents And Keels)
JAZ
Prosthesis, Facial, Mandibular Implant
JOF
Polymer, Ent Synthetic, Porous Polyethylene
JXS
Block, Cutting, Ent, Sterile
JXT
Crimper, Wire, Ent, Sterile
JXW
Die, Wire Bending, Ent, Sterile
JXX
Forceps, Wire Closure, Ent, Sterile
JXY
Jig, Piston Cutting, Ent, Sterile
JXZ
Punch, Gelfoam, Sterile
JYA
Scissors, Wire Cutting, Ent, Sterile
JYB
Vise, Ossicular Finger, Sterile
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
KHL
Hearing Aid, Master
KLW
Masker, Tinnitus
KLZ
Tube, Shunt, Endolymphatic With Valve
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
LBL
Tube, Tympanostomy, Porous Polyethylene
LBM
Porous Polyethylene Ossicular Replacement
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
LDG
Kit, Earmold, Impression
LRB
Face Plate Hearing Aid
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
LWF
Dilator, Nasal
LXB
Hearing Aid, Bone Conduction
LZI
Device, Assistive Listening
MAH
Hearing Aid, Bone Conduction, Implanted
MCK
Device, Voice Amplification
MIX
System, Vocal Cord Medialization
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
NIX
Hearing Aid, Air Conduction, Transcutaneous System
NNN
Crimper, Wire, Ent, Non-Sterile
NNO
Jig, Piston Cutting, Ent, Non-Sterile
NNP
Die, Wire Bending, Ent, Non-Sterile
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
NNR
Block, Cutting, Ent, Non-Sterile
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
NNT
Punch, Gelfoam, Non-Sterile
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
NNV
Vise, Ossicular Finger, Non-Sterile
OGS
Myringotomy Procedure Kit
OSM
Hearing Aid, Air Conduction With Wireless Technology
PFO
Active Implantable Bone Conduction Hearing System
PLK
Tympanic Membrane Direct Contact Hearing Aid
QDD
Self-Fitting Air-Conduction Hearing Aid
QUF
Hearing Aid, Air-Conduction, Over The Counter
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
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-d—prosthetic-devices
/
ETW
/
K801905
View Source
FONIX TYPE 5100 HEARING AID ANALYZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801905
510(k) Type
Traditional
Applicant
FRYE ELECTRONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/1980
Days to Decision
16 days