FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTDOP 45 VASCULAR DOPPLER
K Number: K050601
·
Decision Apr 15, 2005
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
18
Review Days
37
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Basic Information
- Device Name
- SMARTDOP 45 VASCULAR DOPPLER
- K Number
- K050601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koven Technology, Inc.
- Date Received
- March 9, 2005
- Decision Date
- April 15, 2005
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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Other Clearances by Koven Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201114 | Bidop 7 | Jan 5, 2021 | Substantially Equivalent |
| K153762 | Smartdop XT6 | May 25, 2016 | Substantially Equivalent |
| K143332 | Fast Sphyg by Koven | Apr 14, 2015 | Substantially Equivalent |
| K131623 | SMARTDOP XT | Jan 17, 2014 | Substantially Equivalent |
| K080178 | VALVULOTOME BY KOVEN | Jul 28, 2008 | Substantially Equivalent |
| K031931 | ECHO SOUNDER EX-101EX 8 MHZ | Feb 13, 2004 | Substantially Equivalent |
| K031504 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX | Jul 18, 2003 | Substantially Equivalent |
| K023143 | ECHO SOUNDER, ES-102EX | Dec 19, 2002 | Substantially Equivalent |
| K010452 | BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T | Feb 12, 2002 | Substantially Equivalent |
| K982986 | TUBING BLOOD FLOW METER MODEL NUMBER HD-800 | Nov 24, 1998 | Substantially Equivalent |