FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSIGHT MILLENNIUM III
K Number: K023209
·
Decision Oct 10, 2003
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
9
Review Days
379
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Basic Information
- Device Name
- INSIGHT MILLENNIUM III
- K Number
- K023209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fasstech
- Date Received
- September 26, 2002
- Decision Date
- October 10, 2003
- 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 Fasstech
| K Number | Device Name | ||
|---|---|---|---|
| K063447 | INSIGHT DISCOVERY | Aug 16, 2007 | Substantially Equivalent |
| K033452 | CWAS 1000 | Nov 28, 2003 | Substantially Equivalent |
| K011964 | INSIGHT MILLENNIUM PLUS | Sep 20, 2001 | Substantially Equivalent |
| K011983 | INSIGHT GENESIS | Aug 30, 2001 | Substantially Equivalent |
| K990778 | INSIGHT MILLENNIUM | Jun 3, 1999 | Substantially Equivalent |
| K961212 | SPINAL TOUCH | Jun 12, 1996 | Substantially Equivalent |
| K940050 | FOCUS EMG | Feb 24, 1995 | Substantially Equivalent |
| K925197 | PSI 220 DUAL EMG | Feb 2, 1993 | Substantially Equivalent |