FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSIGHT GENESIS
K Number: K011983
·
Decision Aug 30, 2001
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
9
Review Days
65
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSIGHT GENESIS
- K Number
- K011983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fasstech
- Date Received
- June 26, 2001
- Decision Date
- August 30, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HCC), ordered by most recent decision date.
A Breathing System (ABS)
FDA 510(k)
FDA Class 2
·Neurology
Prism
FDA 510(k)
FDA Class 2
·Neurology
Freespira
FDA 510(k)
FDA Class 2
·Neurology
GrindCare System
FDA 510(k)
FDA Class 2
·Neurology
Pacifier Activated Lullaby (PAL®)
FDA 510(k)
FDA Class 2
·Neurology
NFANT Feeding Solution
FDA 510(k)
FDA Class 2
·Neurology
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 |
| 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 |