FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED AXOSTIM
K Number: K896368
·
Decision Nov 27, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
8
Review Days
21
Basic Information
- Device Name
- MODIFIED AXOSTIM
- K Number
- K896368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- SINGER MEDICAL PRODUCTS, INC.
- Date Received
- November 6, 1989
- Decision Date
- November 27, 1989
- Product Code
- BXN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | FDA class 2 | Anesthesiology |
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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 |
| K895784 | IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 | Dec 5, 1989 | Substantially Equivalent |
| K895785 | AUDIOMETER MODEL MD-4, MD-4P | Dec 5, 1989 | Substantially Equivalent |
| K895783 | IMPEDANCE ANALYZER MODELS MD-2, MD-P | Dec 5, 1989 | Substantially Equivalent |
| K883807 | AXOSTIM | Feb 9, 1989 | Substantially Equivalent |