FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDILOG EDITOR
K Number: K890338
·
Decision Apr 19, 1989
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
395
Applicant Total
48
Review Days
86
Basic Information
- Device Name
- MEDILOG EDITOR
- K Number
- K890338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- OXFORD MEDILOG, INC.
- Date Received
- January 23, 1989
- Decision Date
- April 19, 1989
- Product Code
- DSI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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| K896535 | MEDILOG OPTIMA | Jan 18, 1990 | Substantially Equivalent |
| K891383 | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM | Jun 1, 1989 | Substantially Equivalent |
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