Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- NEACement, Ear, Nose And Throat2Product Code
- ESDHearing Aid, Air Conduction1Product Code
- ESELarynx, Artificial (Battery-Powered)1Product Code
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane2Product Code
- ESXTack, Sacculotomy (Cody Tack)2Product Code
- ESZTube, Shunt, Endolymphatic2Product Code
- ETAReplacement, Ossicular Prosthesis, Total2Product Code
- ETBProsthesis, Partial Ossicular Replacement2Product Code
- ETCMold, Middle-Ear2Product Code
- ETDTube, Tympanostomy2Product Code
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- K122028AURICAL HIT2Cleared 510(K)
- K113831PRIMUS HEARING INSTRUMENT TEST UNIT2Cleared 510(K)
- K110286GN OTOMETRICS TYPE 1053 FREEFIT2Cleared 510(K)
- K093006FONIX ,MODEL 80002Cleared 510(K)
- K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)2Cleared 510(K)
- K061104SPEECHLINK 100 TYPE 10532Cleared 510(K)
- K050496REM4402Cleared 510(K)
- K041853OTOGRAM2Cleared 510(K)
- K022510FONIX, MODEL 70002Cleared 510(K)
- K012306AUDIOSCAN VERIFIT, MODEL VF-12Cleared 510(K)
- K980377FONIX FP35 HEARING AID ANALYZER2Cleared 510(K)
- K970324GSI SA60 DPOAE SYSTEM2Cleared 510(K)
- K960229RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM2Cleared 510(K)
- K952098SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE2Cleared 510(K)
- K943459DESKREM-10002Cleared 510(K)
- K943460PORTAREM 20002Cleared 510(K)
- K943607INTERACOUSTICS HEARING AID ANALYZER MS 402Cleared 510(K)
- K941848INTERACOUSTICS. HEARING AID ANALYZER2Cleared 510(K)
- K934342GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM2Cleared 510(K)
- K935400FONIX 3500 HEARING AID ANALYZER2Cleared 510(K)
- K902244RASTRONICS CCI 82Cleared 510(K)
- K902252RASTRONICS CCI 10/3 HEARING AID ANALYSIS2Cleared 510(K)
- K896996CAS (COMPUTERIZED ANALYZER SYSTEM)2Cleared 510(K)
- K896477NICOLET REAL EAR ANALYZER2Cleared 510(K)
- K895383TYPE FP40 DIGITAL HEARING AID ANALYZER2Cleared 510(K)
- K896301MODEL 340 PROBE MIC SYSTEM2Cleared 510(K)
- K884372MADSEN IGO1500 INSERTION GAIN OPTIMIZER2Cleared 510(K)
- K884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM2Cleared 510(K)
- K884046AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM5002Cleared 510(K)
- K872633MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM2Cleared 510(K)
- K872242TYPE 6400 REAL EAR HEARING AID ANALYZER2Cleared 510(K)
- K870337AUDIOMETER2Cleared 510(K)
- K870229HEARING AID TEST SYSTEM MODEL HAT 10002Cleared 510(K)
- K862026HA-2000 REAL EAR SPECTROSCOPE2Cleared 510(K)
- K862162PHONIC EAR, MODEL PE 18002Cleared 510(K)
- K862086IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 18232Cleared 510(K)
- K861857PHONIC EAR2Cleared 510(K)
- K861571TYPE 6500 HEARING AID ANALYZER2Cleared 510(K)
- K861113ER-7C CLINICAL PROBE MICROPHONE2Cleared 510(K)
- K854535INSERTION GAIN OPTIMIZER IGO-10002Cleared 510(K)
- K853271HEARING AID ANALYSIS SYSTEM2Cleared 510(K)
- K853320FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-102Cleared 510(K)
- K850918TYPE FP30 DIGITAL HEARING AID ANALYZER2Cleared 510(K)
- K844275STARKET MODEL HMS2Cleared 510(K)
- K821908STARKEY MODEL HAL-12Cleared 510(K)
- K801905FONIX TYPE 5100 HEARING AID ANALYZER2Cleared 510(K)
- EWLProsthesis, Laryngeal (Taub)2Product Code
- FWNProsthesis, Larynx (Stents And Keels)2Product Code
- JAZProsthesis, Facial, Mandibular Implant2Product Code
- JOFPolymer, Ent Synthetic, Porous Polyethylene2Product Code
- JXSBlock, Cutting, Ent, Sterile1Product Code
- JXTCrimper, Wire, Ent, Sterile1Product Code
- JXWDie, Wire Bending, Ent, Sterile1Product Code
- JXXForceps, Wire Closure, Ent, Sterile1Product Code
- JXYJig, Piston Cutting, Ent, Sterile1Product Code
- JXZPunch, Gelfoam, Sterile1Product Code
- JYAScissors, Wire Cutting, Ent, Sterile1Product Code
- JYBVise, Ossicular Finger, Sterile1Product Code
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2Product Code
- KHLHearing Aid, Master2Product Code
- KLWMasker, Tinnitus2Product Code
- KLZTube, Shunt, Endolymphatic With Valve2Product Code
- KQLTube, Tympanostomy With Semi-Permeable Membrane2Product Code
- LBLTube, Tympanostomy, Porous Polyethylene2Product Code
- LBMPorous Polyethylene Ossicular Replacement2Product Code
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene2Product Code
- LBPReplacement, Ossicular (Stapes) Using Absorbable Gelatin Material2Product Code
- LDGKit, Earmold, Impression1Product Code
- LRBFace Plate Hearing Aid1Product Code
- LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile1Product Code
- LWFDilator, Nasal1Product Code
- LXBHearing Aid, Bone Conduction2Product Code
- LZIDevice, Assistive Listening2Product Code
- MAHHearing Aid, Bone Conduction, Implanted2Product Code
- MCKDevice, Voice Amplification2Product Code
- MIXSystem, Vocal Cord Medialization2Product Code
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2Product Code
- NIXHearing Aid, Air Conduction, Transcutaneous System2Product Code
- NNNCrimper, Wire, Ent, Non-Sterile1Product Code
- NNOJig, Piston Cutting, Ent, Non-Sterile1Product Code
- NNPDie, Wire Bending, Ent, Non-Sterile1Product Code
- NNQForceps, Wire Closure, Ent, Non-Sterile1Product Code
- NNRBlock, Cutting, Ent, Non-Sterile1Product Code
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile1Product Code
- NNTPunch, Gelfoam, Non-Sterile1Product Code
- NNUScissors, Wire Cutting, Ent, Non-Sterile1Product Code
- NNVVise, Ossicular Finger, Non-Sterile1Product Code
- OGSMyringotomy Procedure Kit2Product Code
- OSMHearing Aid, Air Conduction With Wireless Technology2Product Code
- PFOActive Implantable Bone Conduction Hearing System2Product Code
- PLKTympanic Membrane Direct Contact Hearing Aid2Product Code
- QDDSelf-Fitting Air-Conduction Hearing Aid2Product Code
- QUFHearing Aid, Air-Conduction, Over The Counter1Product Code
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter2Product Code
- QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
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- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PORTAREM 2000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K943460
- 510(k) Type
- Traditional
- Applicant
- STARKEY LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/21/1994
- Days to Decision
- 95 days
- Submission Type
- Summary