FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K Number: K863724
·
Decision Nov 20, 1986
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
48
Review Days
58
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Basic Information
- Device Name
- MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
- K Number
- K863724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Oxford Medilog, Inc.
- Date Received
- September 23, 1986
- Decision Date
- November 20, 1986
- 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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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 |