Medical device licence · 63158 · Class 2
K4000 MICROKERATOME SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed October 29, 2003; ended March 4, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63158
- Licence holder
- Becton Dickinson And CompanyFranklin Lakes, New Jersey, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 29, 2003
- Ended
- March 4, 2004
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- K4000 MICROKERATOME CONSOLE
- K4000 MICROKERATOME FOOTSWITCH
- K4000 MICROKERATOME SYSTEM
- K4000 MICROKERATOME SYSTEM - BLADE CHANGER
- K4000 MICROKERATOME SYSTEM - HANDPIECE MANUAL
- K4000 MICROKERATOME SYSTEM - KERATOME HEAD
- K4000 MICROKERATOME SYSTEM - STERILIZATION COMPONENTS
- K4000 MICROKERATOME SYSTEM - SUCTION RING
- K4000 MICROKERATOME SYSTEM -APPLANATOR
- K4000 MICROKERATOME SYSTEM -BLADES
- K4000 MICROKERATOME TUBING SET
- K4000 MICROKERTOME BATTERY CHARGER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.