FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
USG 2000SA
K Number: K023227
·
Decision Oct 22, 2002
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
25
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Basic Information
- Device Name
- USG 2000SA
- K Number
- K023227
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.2225
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultraguide , Ltd.
- Date Received
- September 27, 2002
- Decision Date
- October 22, 2002
- Product Code
- HHJ
- 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 |
|---|---|---|---|
| HHJ | Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic | FDA class 2 | Obstetrics/Gynecology |
Other Clearances by Ultraguide , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K022354 | ULTRAGUIDE CTG 2000SA | Aug 13, 2002 | Substantially Equivalent |
| K013150 | MR-GUIDE 2000 | Oct 18, 2001 | Substantially Equivalent |
| K011418 | ULTRAGUIDE MR-GUIDE 3000 | May 24, 2001 | Substantially Equivalent |
| K002258 | ULTRAGUIDE CT-GUIDE 1010 | Aug 8, 2000 | Substantially Equivalent |
| K974432 | ULTRAGUIDE 1000 | Feb 9, 1998 | Substantially Equivalent |