FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLAT VASCULAR PROBE
K Number: K896613
·
Decision Feb 16, 1990
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
19
Review Days
87
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Basic Information
- Device Name
- FLAT VASCULAR PROBE
- K Number
- K896613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Imex Medical Systems, Inc.
- Date Received
- November 21, 1989
- Decision Date
- February 16, 1990
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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Other Clearances by Imex Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973556 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 | Apr 24, 1998 | Substantially Equivalent |
| K973562 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 | Apr 15, 1998 | Substantially Equivalent |
| K973336 | IMEX STETHODOP | Feb 5, 1998 | Substantially Equivalent |
| K970156 | IMEX FUTURALDOP PRO | Apr 4, 1997 | Substantially Equivalent |
| K942243 | IMEX 8000 PERSONAL CASCULAR LAB | Nov 3, 1995 | Substantially Equivalent |
| K944196 | IMWXDOP IR | May 12, 1995 | Substantially Equivalent |
| K942441 | IMEXDOP CT+ | Aug 23, 1994 | Substantially Equivalent |
| K910462 | POCKET DOP 3 | Jun 24, 1991 | Substantially Equivalent |
| K901593 | IMEX DOP-TONE II | Jul 2, 1990 | Substantially Equivalent |
| K882138 | IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER | Nov 7, 1988 | Substantially Equivalent |