FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
K Number: K860458
·
Decision Aug 12, 1986
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
48
Review Days
188
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
- ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
- K Number
- K860458
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Oxford Medilog, Inc.
- Date Received
- February 5, 1986
- Decision Date
- August 12, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLV), ordered by most recent decision date.
Noxturnal Web
FDA 510(k)
FDA Class 2
·Neurology
Falcon HST
FDA 510(k)
FDA Class 2
·Neurology
Noxturnal Web
FDA 510(k)
FDA Class 2
·Neurology
HomeSleepTest (HST, HST REM+)
FDA 510(k)
FDA Class 2
·Neurology
Cerebra Sleep System
FDA 510(k)
FDA Class 2
·Neurology
SOMNOscreen plus
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Oxford Medilog, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923737 | MODEL MEDILOG RAPIDE | Jan 5, 1994 | Substantially Equivalent |
| K920295 | MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) | Aug 18, 1992 | Substantially Equivalent |
| K912890 | MODEL SONICAID AXIS | Jan 9, 1992 | Substantially Equivalent |
| K912639 | SONICAID TEAM | Dec 31, 1991 | Substantially Equivalent |
| K904763 | MENTOR EEG SYSTEM | Apr 10, 1991 | Substantially Equivalent |
| K902690 | SONICAID MODEL MERIDIAN 800 | Feb 5, 1991 | Substantially Equivalent |
| K895909 | SONICAID MODEL VASOFLO 4 | Jul 9, 1990 | Substantially Equivalent |
| K896535 | MEDILOG OPTIMA | Jan 18, 1990 | Substantially Equivalent |
| K891383 | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM | Jun 1, 1989 | Substantially Equivalent |
| K890330 | MEDILOG 6000-FD REPORT GENERATOR | Apr 20, 1989 | Substantially Equivalent |