FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
HARMONIE SENSA
K Number: K960273
·
Decision Apr 4, 1996
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
7
Review Days
76
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Basic Information
- Device Name
- HARMONIE SENSA
- K Number
- K960273
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stellate Systems
- Date Received
- January 19, 1996
- Decision Date
- April 4, 1996
- Product Code
- OMB
- 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 |
|---|---|---|---|
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Stellate Systems
| K Number | Device Name | ||
|---|---|---|---|
| K083577 | HARMONIE SYSTEM | Aug 29, 2011 | Substantially Equivalent |
| 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 |
| K912938 | RHYTHM | Jul 30, 1991 | Substantially Equivalent |