FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ADVANTAGE EMG SYSTEM, MODEL #A100
K Number: K974010
·
Decision Jan 16, 1998
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
2
Review Days
87
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Basic Information
- Device Name
- ADVANTAGE EMG SYSTEM, MODEL #A100
- K Number
- K974010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advantage Medical Division of Cme Telemetrix
- Date Received
- October 21, 1997
- Decision Date
- January 16, 1998
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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Other Clearances by Advantage Medical Division of Cme Telemetrix
| K Number | Device Name | ||
|---|---|---|---|
| K973355 | ADVANTAGE 3000 | Dec 5, 1997 | Substantially Equivalent |