FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
K Number: K050088
·
Decision Feb 8, 2005
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
6
Review Days
26
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Basic Information
- Device Name
- QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
- K Number
- K050088
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neoprobe Corp.
- Date Received
- January 13, 2005
- Decision Date
- February 8, 2005
- 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 Neoprobe Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Jun 26, 1997 | Substantially Equivalent |
| K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | Sep 13, 1996 | Substantially Equivalent |
| K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Feb 9, 1995 | Substantially Equivalent |
| K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Jun 10, 1992 | Substantially Equivalent |
| K864263 | NEOPROBE PORTABLE RADIOISOTOPE DETECTOR | Dec 29, 1986 | Substantially Equivalent |