Definition: This Product Code Is The Class II Exempt Counterpart Of ETY, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k))
| Device Type ID | 1641 |
| Device Name | Tester, Auditory Impedance, Exempt |
| Physical State | Exemption Is Limited To Auditory Impedance Testers That Are In Compliance With FDA-recognized Consensus Standard ANSI S3.39. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of ETY, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Target Area | This Product Code Is The Class II Exempt Counterpart Of ETY, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Regulation Description | Auditory Impedance Tester. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 874.1090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1641 |
| Device | Tester, Auditory Impedance, Exempt |
| Product Code | PTO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Auditory Impedance Tester. |
| CFR Regulation Number | 874.1090 [🔎] |