510(k) K023227
K023227 is an FDA 510(k) premarket notification submitted by Ultraguide , Ltd. for the device "USG 2000SA". The FDA issued a decision of Substantially Equivalent on October 22, 2002. The device falls under product code HHJ (Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Ultraguide , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2002
- Date Received
- September 27, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
- Device Class
- Class II
- Regulation Number
- 884.2225
- Review Panel
- OB
- Submission Type