FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM
K Number: K860219
·
Decision Apr 17, 1986
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
12
Review Days
85
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Basic Information
- Device Name
- SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM
- K Number
- K860219
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Grass-Telefactor Product Group
- Date Received
- January 22, 1986
- Decision Date
- April 17, 1986
- Product Code
- OLV
- 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 |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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