FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EARCHECK PRO
K Number: K970685
·
Decision May 28, 1997
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
2
Review Days
93
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Basic Information
- Device Name
- EARCHECK PRO
- K Number
- K970685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mdi Instruments, Inc.
- Date Received
- February 24, 1997
- Decision Date
- May 28, 1997
- 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 Mdi Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971859 | EARCHECK | Aug 18, 1997 | Substantially Equivalent |