Anesthesiology
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- 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
- 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
- K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand2Cleared 510(K)
- K243041contact forte Alpha2Cleared 510(K)
- K213733Ponto 5 SuperPower2Cleared 510(K)
- K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App2Cleared 510(K)
- K211640Ponto 5 Mini2Cleared 510(K)
- K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App2Cleared 510(K)
- K190540Ponto 42Cleared 510(K)
- K172460ADHEAR System2Cleared 510(K)
- K171088Cochlear Baha SoundArc2Cleared 510(K)
- K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPower2Cleared 510(K)
Show All 49 Submissions
- 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
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Ponto 4
- Page Type
- Cleared 510(K)
- 510(k) Number
- K190540
- 510(k) Type
- Traditional
- Applicant
- Oticon Medical AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/2/2019
- Days to Decision
- 59 days
- Submission Type
- Summary