FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
HARMONIE SYSTEM
K Number: K083577
·
Decision Aug 29, 2011
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
7
Review Days
999
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Basic Information
- Device Name
- HARMONIE SYSTEM
- K Number
- K083577
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stellate Systems
- Date Received
- December 3, 2008
- Decision Date
- August 29, 2011
- Product Code
- GWQ
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Stellate Systems
| K Number | Device Name | ||
|---|---|---|---|
| K013450 | NOTTA AMBULATORY RECORDER | Jan 14, 2002 | Substantially Equivalent |
| K010728 | HARMONE-SCHWARZER EEG SYSTEM | May 21, 2001 | Substantially Equivalent |
| K982351 | LUNA | Jul 29, 1998 | Substantially Equivalent |
| K955577 | ECLIPSE VERSION 3.0 | Sep 20, 1996 | Substantially Equivalent |
| K960273 | HARMONIE SENSA | Apr 4, 1996 | Substantially Equivalent |
| K912938 | RHYTHM | Jul 30, 1991 | Substantially Equivalent |