FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPEDANCE ANALYZER MODELS MD-2, MD-P
K Number: K895783
·
Decision Dec 5, 1989
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
8
Review Days
132
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Basic Information
- Device Name
- IMPEDANCE ANALYZER MODELS MD-2, MD-P
- K Number
- K895783
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Singer Medical Products, Inc.
- Date Received
- July 26, 1989
- Decision Date
- December 5, 1989
- 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 |
Similar 510(k) Clearances
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FDA 510(k)
FDA Class 2
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Other Clearances by Singer Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION | Apr 19, 1991 | Substantially Equivalent |
| K896909 | MD5 AUTOMATIC AUDIOMETER | Mar 5, 1990 | Substantially Equivalent |
| K894748 | IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P | Dec 5, 1989 | Substantially Equivalent |
| K895785 | AUDIOMETER MODEL MD-4, MD-4P | Dec 5, 1989 | Substantially Equivalent |
| K895784 | IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 | Dec 5, 1989 | Substantially Equivalent |
| K896368 | MODIFIED AXOSTIM | Nov 27, 1989 | Substantially Equivalent |
| K883807 | AXOSTIM | Feb 9, 1989 | Substantially Equivalent |