510(k) DEN060006
- Device
- COMPUTERIZED LABOR MONITORING SYSTEM
- Applicant
- Barnev, Ltd.
- 510(k) number
- DEN060006
- Product code
- NPB
- Decision
- Unknown (DENG)
- Decision date
- 2007-01-30
- Date received
- 2006-10-18
- Regulation
- 884.2800
- Classification name
- System, Monitoring, For Progress Of Labor
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- ARAVA HACOHEN
- Address
- 20 Hata'As St. Beit Hapa'Amon (Box 124) Kfar Saba IL 44425 44425
Source Documents#
510(k) summary PDF not indicated by FDA