510(k) K023082
- Device
- BABYCARE
- Applicant
- Bionet Company, Ltd.
- 510(k) number
- K023082
- Product code
- HEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-03-03
- Date received
- 2002-09-17
- Regulation
- 884.2660
- Classification name
- Monitor, Blood-Flow, Ultrasonic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- JAY MANSOUR
- Address
- 1308 Morningside Park Dr. Alpharetta GA US 30022 30022
FDA Registration Numbers#
- 3010611950
- 1216677
- 3003971136
- 3003681187
- 1000122786
- 3009499478
- 1066270