FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Madsen Zodiac
K Number: K161707
·
Decision Sep 1, 2016
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
8
Review Days
72
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Basic Information
- Device Name
- Madsen Zodiac
- K Number
- K161707
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gn Otometrics
- Date Received
- June 21, 2016
- Decision Date
- September 1, 2016
- Product Code
- ETY
- 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Gn Otometrics
| K Number | Device Name | ||
|---|---|---|---|
| K151504 | ICS Impulse | Nov 16, 2015 | Substantially Equivalent |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | Feb 27, 2014 | 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 |