FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
K Number: K910771
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
3
Review Days
299
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Basic Information
- Device Name
- DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
- K Number
- K910771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- New England Medical Instruments, Inc.
- Date Received
- February 22, 1991
- Decision Date
- December 18, 1991
- 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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