FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMNITOR 32K SLEEP ACTIVITY MONITOR
K Number: K965079
·
Decision Jul 10, 1997
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
18
Applicant Total
1
Review Days
203
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Basic Information
- Device Name
- SOMNITOR 32K SLEEP ACTIVITY MONITOR
- K Number
- K965079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurim Pharmaceuticals, Ltd.
- Date Received
- December 19, 1996
- Decision Date
- July 10, 1997
- Product Code
- LEL
- 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 |
|---|---|---|---|
| LEL | Device, Sleep Assessment | FDA class 2 | Neurology |
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