FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSIGHT MILLENNIUM
K Number: K990778
·
Decision Jun 3, 1999
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
9
Review Days
86
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Basic Information
- Device Name
- INSIGHT MILLENNIUM
- K Number
- K990778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fasstech
- Date Received
- March 9, 1999
- Decision Date
- June 3, 1999
- Product Code
- HCC
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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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 |
| K023209 | INSIGHT MILLENNIUM III | Oct 10, 2003 | Substantially Equivalent |
| K011964 | INSIGHT MILLENNIUM PLUS | Sep 20, 2001 | Substantially Equivalent |
| K011983 | INSIGHT GENESIS | Aug 30, 2001 | 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 |