FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL K7 EVALUATION DEVICE
K Number: K003287
·
Decision Nov 6, 2000
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
7
Review Days
17
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Basic Information
- Device Name
- MODEL K7 EVALUATION DEVICE
- K Number
- K003287
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Myotronics-Noromed, Inc.
- Date Received
- October 20, 2000
- Decision Date
- November 6, 2000
- Product Code
- KZM
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| KZM | Device, Muscle Monitoring | FDA class 2 | Physical Medicine |
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Other Clearances by Myotronics-Noromed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111687 | EMG SYSTEM | Sep 29, 2011 | Substantially Equivalent |
| K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | Jul 20, 2004 | Substantially Equivalent |
| K031998 | MODEL J-5 MVO-MONITOR | Jul 24, 2003 | Substantially Equivalent |
| K013399 | MODEL MES-9000/EMG SYSTEM | Nov 13, 2001 | Substantially Equivalent |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | Sep 10, 1999 | Substantially Equivalent |
| K992439 | NORODYN 8000 SEMG SYSTEM, ND-8000 | Aug 13, 1999 | Substantially Equivalent |