FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B SMART MODEL 1
K Number: K961817
·
Decision Jul 23, 1997
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
18
Applicant Total
18
Review Days
439
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Basic Information
- Device Name
- B SMART MODEL 1
- K Number
- K961817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koven Technology, Inc.
- Date Received
- May 10, 1996
- Decision Date
- July 23, 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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