BTL BTL Laser User manual
DECLARATION OF CONFORMITY
for CE – marking according to Annex II
of Medical Devices Directive 93/42/EEC
Manufacturer:
Suite 401 Albany House
324-326 Regents Street
London
WIB 3BL
United Kingdom
The BTL Industries Ltd. herewith declares under its sole responsibility that the product
Product Name:
Type:
BTL-4000 Series v1.xx
Product Name:
Type:
BTL-5000 Puls v1.xx
BTL-4000 Puls v1.xx
Product Name:
Type:
BTL vac v1.xx
Product Name:
Type:
BTL-5000 Sono v1.xx
BTL-4000 Sono v1.xx
Product Name:
Type:
BTL-2000 v5.xx
BTL-5000 Laser v1.xx
BTL-4000 Laser v1.xx
Product Name:
Type:
Risk Classification:
conforms with the applicable regulation:
Directive:
Quality Assurance Standards:
Procedural Standards:
EN 60601-1 + A2
EN 60601-2-10
EN 60601-2-5
EN 60601-2-22
EN 60825-1
EN ISO 14971
ISO 10993-1
BTL Industries Limited
Combined therapy devices
BTL-5000 Series v1.xx
Electrotherapy devices
BTL-06 v3.xx
Ultraound therapy devices
BTL-12 v2.xx
Ultraound therapy devices
BTL-07p v4.xx
Laser therapy devices
BTL-10 v5.xx
Magnetotherapy devices
BTL-09 v4.xx
Class IIb
MDD 93/42/EEC
ISO 13485 : 2003
EN 60601-1-1
EN 60601-1-2
th
Date of Issue: 24
Place of Issue: London
Daniela Marx
Director of BTL Industries Limited
February 2004 Signature:
Loading...