FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERSYST REVEAL
K Number: K011397
·
Decision Aug 3, 2001
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
4
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PERSYST REVEAL
- K Number
- K011397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Persyst Development Corp.
- Date Received
- May 7, 2001
- Decision Date
- August 3, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMB), ordered by most recent decision date.
Ceribell Infant Seizure Detection Software
FDA 510(k)
FDA Class 2
·Neurology
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
FDA 510(k)
FDA Class 2
·Neurology
Ceribell Seizure Detection Software
FDA 510(k)
FDA Class 2
·Neurology
autoSCORE (V 2.0.0)
FDA 510(k)
FDA Class 2
·Neurology
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
FDA 510(k)
FDA Class 2
·Neurology
NeuroMatch
FDA 510(k)
FDA Class 2
·Neurology