FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMPLAID EMG15
K Number: K884071
·
Decision Feb 27, 1989
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
4
Review Days
153
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Basic Information
- Device Name
- AMPLAID EMG15
- K Number
- K884071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Amplus Corp.
- Date Received
- September 27, 1988
- Decision Date
- February 27, 1989
- Product Code
- GWL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | FDA class 2 | Neurology |
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