Maico MB 11 with Beraphone Probe
FDA 510(k) K082035 · Maico Diagnostics
510(k) numberK082035
Submission
- Device name
- Maico MB 11 with Beraphone Probe
- Applicant
- Maico Diagnostics
Minnesota, MN, US - Received
- July 17, 2008
- Decision date
- January 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K163326 | SmartEPGWJ · Traditional | Intelligent Hearing Systems | 09/29/2017SE |
| K162037 | Eclipse with VEMPGWJ · Traditional | Interacoustics A/S | 03/23/2017SE |
| K143670 | Ics Chartr Ep 200 with VempGWJ · Traditional | Gn Otometrics A/S | 10/23/2015SE |
| K141446 | Echo-Screen III Pro Hearing Screener with Barcode Scanner, Echo-Screen III Pro Hearing…GWJ · Special | Natus Medical Incorporated | 08/22/2014SE |
| K132957 | Madsen Accuscreen Type 1077GWJ · Traditional | Gn Otometrics | 02/27/2014SE |
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Questions and answers
When was Maico MB 11 with Beraphone Probe cleared by the FDA?
Maico MB 11 with Beraphone Probe (K082035) received a 510(k) decision of Substantially Equivalent on January 29, 2009, 196 days after the submission was received.
What is the product code of K082035?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.