FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDILOG FD4
K Number: K970902
·
Decision May 5, 1997
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
5
Review Days
55
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Basic Information
- Device Name
- MEDILOG FD4
- K Number
- K970902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oxford Instruments Medical Systems
- Date Received
- March 11, 1997
- Decision Date
- May 5, 1997
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Oxford Instruments Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K992607 | SONICAID SYSTEM 8002 | Apr 27, 2001 | Substantially Equivalent |
| K984052 | SYNERGY IOM SYSTEM | May 17, 1999 | Substantially Equivalent |
| K961638 | MEDILOG MPA-S | Jan 17, 1997 | Substantially Equivalent |
| K943862 | SONICAID MODEL MR-63 AMBULATORY ECG RECORDER | Jun 7, 1995 | Substantially Equivalent |