FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Lyra
K Number: K191372
·
Decision Jul 15, 2019
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
17
Review Days
54
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Basic Information
- Device Name
- Lyra
- K Number
- K191372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interacoustics A/S
- Date Received
- May 22, 2019
- Decision Date
- July 15, 2019
- Product Code
- EWO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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|---|---|---|---|
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| K200529 | Orion | Aug 12, 2020 | Substantially Equivalent |
| K192652 | TRV | May 27, 2020 | Substantially Equivalent |
| K173567 | Sera | Feb 14, 2018 | Substantially Equivalent |
| K163149 | VisualEyes | Apr 26, 2017 | Substantially Equivalent |
| K162037 | Eclipse with VEMP | Mar 23, 2017 | Substantially Equivalent |
| K152112 | VisualEyes | Dec 29, 2015 | Substantially Equivalent |
| K151616 | AT235 | Jul 15, 2015 | Substantially Equivalent |
| K131681 | EYESEECAM VHIT | Sep 6, 2013 | Substantially Equivalent |
| K130795 | TITAN | Jun 20, 2013 | Substantially Equivalent |