FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MADSEN ACCUSCREEN TYPE 1077
K Number: K132957
·
Decision Feb 27, 2014
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
8
Review Days
160
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Basic Information
- Device Name
- MADSEN ACCUSCREEN TYPE 1077
- K Number
- K132957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gn Otometrics
- Date Received
- September 20, 2013
- Decision Date
- February 27, 2014
- Product Code
- GWJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Gn Otometrics
| K Number | Device Name | ||
|---|---|---|---|
| K161707 | Madsen Zodiac | Sep 1, 2016 | Substantially Equivalent |
| K151504 | ICS Impulse | Nov 16, 2015 | Substantially Equivalent |
| K122550 | ICS IMPULSE | Feb 1, 2013 | Substantially Equivalent |
| K122028 | AURICAL HIT | Oct 23, 2012 | Substantially Equivalent |
| K122067 | TYPE 1077 ACCUSCREEN | Sep 27, 2012 | Substantially Equivalent |
| K092373 | ICS CHARTR EP 200 | Sep 3, 2009 | Substantially Equivalent |
| K081234 | GN OTOMETRICS INSERT EARPHONES | Jul 14, 2008 | Substantially Equivalent |