General Information Preva
4
EC Declaration of Conformity
Name and
Description of
Product
Progeny Preva
Catalog
Model
P7017, 76 inch reach
30-A0010, Control
30-A2071, Extension Arm, Long
Catalog
Model
P7016, 66 inch reach
30-A0010, Control
30-A2073, Extension Arm, Short
Catalog
Model
P7015, 56 inch reach
30-A0010, Control
30-A2074, Extension Arm, Compact
Catalog
Model
P7017-MG, Mobile
30-A0010, Control
Class: IIb
Reference
Numbers to
which
Conformity is
Declared
The following regulatory documents apply:
UL 2601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32
Medical Device directive
ISO 13485
EN46001
FDA 510K File Number K043092
Declaration
Progeny, Inc. declares that the products described herein meet all the applicable
Essential Requirements of the EC Medical Device Directive 93/42/EEC in Annex
I. For Class IIb products described herein, the product is manufactured,
inspected, tested and released in accordance with the approved quality
assurance system established in accordance with ISO 13485 and Annex II of the
EC Medical Device Directive under the Supervision of the SGS United Kingdom
Ltd., a Notified Body.
Contact
Technical Support
Progeny, Inc.
[email protected]
