FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K Number: K031504
·
Decision Jul 18, 2003
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
18
Review Days
65
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
- K Number
- K031504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koven Technology, Inc.
- Date Received
- May 14, 2003
- Decision Date
- July 18, 2003
- Product Code
- KNG
- Advisory Committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNG), ordered by most recent decision date.
Fetal Doppler U8-25, U9-25
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Doppler FHR Detector (BF-500D+, BF-560)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ultrasonic Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| K050601 | SMARTDOP 45 VASCULAR DOPPLER | Apr 15, 2005 | Substantially Equivalent |
| K031931 | ECHO SOUNDER EX-101EX 8 MHZ | Feb 13, 2004 | 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 |