FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOSCOPE SUPER VASCULAR LAB
K Number: K943200
·
Decision Nov 21, 1995
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
37
Applicant Total
5
Review Days
504
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Basic Information
- Device Name
- FLOSCOPE SUPER VASCULAR LAB
- K Number
- K943200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1540
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advance Medical Device, Inc.
- Date Received
- July 5, 1994
- Decision Date
- November 21, 1995
- Product Code
- JAF
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | FDA class 2 | Radiology |
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Other Clearances by Advance Medical Device, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964697 | AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION | Feb 11, 1997 | Substantially Equivalent |
| K910441 | FLOSCOPE MICRODOP | Mar 21, 1991 | Substantially Equivalent |
| K905157 | FLOSCOPE VASCULAR LAB. | Mar 15, 1991 | Substantially Equivalent |
| K903744 | PHYSICIAN'S CHOICE | Sep 12, 1990 | Substantially Equivalent |