USG 2000SA
FDA 510(k) clearance K023227 · decided 2002-10-22
Clearance details
- K-number
- K023227
- Device name
- USG 2000SA
- Applicant
- Ultraguide , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-27
- Decision date
- 2002-10-22
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- HHJ
- Device class
- 2
- Regulation number
- 884.2225
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hasbrouck Heights, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ultraguide
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.