510(k) K920740
- Device
- EPISENSOR PLUS
- Applicant
- Industrias Palex C/O Dma Med-Chem Corp.
- 510(k) number
- K920740
- Product code
- CAR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-07
- Date received
- 1992-02-19
- Regulation
- 880.2460
- Classification name
- Monitor, Spinal-Fluid Pressure, Electrically Powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- ARCADI PRIETO
- Address
- Carretera De Terrassa 121 08191 Rubi. Barcelona Spain ES
Source Documents#
510(k) summary PDF not indicated by FDA