510(k) K023227
- Device
- USG 2000SA
- Applicant
- ULTRAGUIDE LTD.
- 510(k) number
- K023227
- Product code
- HHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-22
- Date received
- 2002-09-27
- Regulation
- 884.2225
- Classification name
- Locator, Intracorporeal Device, Ultrasonic, Obstetric-gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE MYERS
- Address
- 377 Rte. 17 S. Hasbrouck Heights NJ US 07601 07601
Source Documents#
Legacy Summary#
summary
FDA Review#
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