FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
AUDIOSCAN VERIFIT, MODEL VF-1
K Number: K012306
·
Decision Sep 21, 2001
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
45
Applicant Total
2
Review Days
60
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Basic Information
- Device Name
- AUDIOSCAN VERIFIT, MODEL VF-1
- K Number
- K012306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3310
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Etymonic Design, Inc.
- Date Received
- July 23, 2001
- Decision Date
- September 21, 2001
- Product Code
- ETW
- 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 |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Etymonic Design, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884046 | AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 | Feb 13, 1989 | Substantially Equivalent |