FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PW DOPPLER VASCULAR PROBES
K Number: K935994
·
Decision May 11, 1995
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
18
Review Days
512
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Basic Information
- Device Name
- PW DOPPLER VASCULAR PROBES
- K Number
- K935994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Koven Technology, Inc.
- Date Received
- December 15, 1993
- Decision Date
- May 11, 1995
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
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|---|---|---|---|
| K201114 | Bidop 7 | Jan 5, 2021 | Substantially Equivalent |
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| 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 |
| K050601 | SMARTDOP 45 VASCULAR DOPPLER | Apr 15, 2005 | 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 |