FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL SONICAID AXIS
K Number: K912890
·
Decision Jan 9, 1992
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
48
Review Days
192
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Basic Information
- Device Name
- MODEL SONICAID AXIS
- K Number
- K912890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oxford Medilog, Inc.
- Date Received
- July 1, 1991
- Decision Date
- January 9, 1992
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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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 |
| 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 |
| K890338 | MEDILOG EDITOR | Apr 19, 1989 | Substantially Equivalent |