510(k) K854410
- Device
- Veriflex
- Applicant
- OLD DELFT CORP. OF AMERICA
- 510(k) number
- K854410
- Product code
- KPZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-12
- Date received
- 1985-11-01
- Regulation
- 892.5900
- Classification name
- Generator, High Voltage, X-Ray, Therapeutic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES PATTIE
- Address
- 2735 Dorr Ave. Fairfax VA US 22031 22031
Source Documents#
510(k) summary PDF not indicated by FDA