FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFEDOP DOPPLER
K Number: K024197
·
Decision Jan 3, 2003
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
7
Review Days
14
Basic Information
- Device Name
- LIFEDOP DOPPLER
- K Number
- K024197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Summit Doppler Systems, Inc.
- Date Received
- December 20, 2002
- Decision Date
- January 3, 2003
- Product Code
- KNG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- Third Party
- Y
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 |
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Other Clearances by Summit Doppler Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K103693 | VANTAGE ABI | Feb 15, 2011 | Substantially Equivalent |
| K101816 | STN PROBE | Aug 19, 2010 | Substantially Equivalent |
| K093393 | LIFEDOP MODEL 300ABI | Dec 24, 2009 | Substantially Equivalent |
| K090499 | LIFEDOP MODEL, L350R | Mar 31, 2009 | Substantially Equivalent |
| K063600 | VISTA AVS | Dec 19, 2006 | Substantially Equivalent |
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | Apr 10, 2006 | Substantially Equivalent |