Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- K133352HYPERSOUND AUDIO SYSTEM (HSS)2Cleared 510(K)
- K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION2Cleared 510(K)
- K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT2Cleared 510(K)
- K974287FM RECEIVER - AUDITORY TRAINER2Cleared 510(K)
- K970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPER2Cleared 510(K)
- K970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPER2Cleared 510(K)
- K960567HF MEGA EAR2Cleared 510(K)
- K950730GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)2Cleared 510(K)
- K941768PHONAK MICROVOX RESONAL FM SYSTEM2Cleared 510(K)
- K940313PHONIC EAR2Cleared 510(K)
- K923234PE 400IR, PE 400T, PE 400E2Cleared 510(K)
- K922720GROUP AUDITORY TRAINING SYSTEM2Cleared 510(K)
- K922570RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-12Cleared 510(K)
- K915384TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER2Cleared 510(K)
- K915398TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER2Cleared 510(K)
- K915397TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER2Cleared 510(K)
- K915383TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER2Cleared 510(K)
- K913495TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC2Cleared 510(K)
- K913494TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC2Cleared 510(K)
- K912356GROUP AUDITORY TRAINER,FM RECEIVER2Cleared 510(K)
- K893431AUDITORY TRAINER PE150R FM RECEIVER2Cleared 510(K)
- K882409PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER2Cleared 510(K)
- K881099PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER2Cleared 510(K)
- K862773PHONIC EAR, MODEL PE475R2Cleared 510(K)
- K832190METAVOX MV-1000 AUDITORY TRAINER2Cleared 510(K)
- K832080PHONIC EAR PE 467R-PE 461T2Cleared 510(K)
- K821691STIMRITE2Cleared 510(K)
- K821511POWERED MUSCLE STIMULATOR2Cleared 510(K)
- K810031STEREO AUDITORY TRAINER (MODEL PM228)2Cleared 510(K)
- K780936PHONIC EAR2Cleared 510(K)
- K771671AUDITORY TRAINER2Cleared 510(K)
- K771357GROUP AUDITORY TRAINER HC 431R2Cleared 510(K)
- 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
- 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
- HematologyReview Panel
- 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
STIMRITE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K821691
- 510(k) Type
- Traditional
- Applicant
- BIOTONE INTERNATIONAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/25/1982
- Days to Decision
- 78 days