Precision Medical Chrome Flowmeters - Manual (Page 7)

DECLARATION OF CONFORMITY
Precision Medical, Inc.
300 Held Drive
Northampton, PA 18067, USA
Emergo Europe (European Office)
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570 Fax: +31 (0) 70.346.7299
Flowmeters 1MFA, 4MFA, 6MFA & 8MFA Series
Classification: IIa
Classification criteria: Clause 3.2 Rule 11 of Annex IX of MDD
We hereby declare that an examination of the under mentioned production quality assurance system has
been carried out following the requirements of the UK national legislation to which the undersigned is
subjected, transposing Annex II, 3 of the Directive 93/42/EEC and Directive 2007/47/EC on medical devices.
We certify that the production quality system conforms to the relevant provisions of the aforementioned
legislation, and the result entitles the organization to use the CE 0473 marking on those products listed above.
Applied Standards: EN 1041, EN 14971, EN ISO 13485, ISO 15001, ISO 15002, ISO 15223-1
Notified Body:
AMTAC Certification Services Limited
Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK
Certification Registration No’s: 1126 CE Date of Expiry: 03 August 2017
Devices already manufactured: S/N traceability Device History Records
Validity of DOC: 04 August 2012 to Date of Expiry
Manufacture Representative: Quality Manager
Position: Quality Systems/ISO Representative
Date of Issue: 04 August 2012
REPLACEMENT PARTS *
PART
MODEL #
6MFA 4MFA 1MFA
1001 3001 3501 4001 1001 8001 5001 1101 1211 2001 9001
Spring NA 1575 NA
Washer NA 1787 NA
Disc NA 1009 1114 1009 1114 1009
Housing 1143
Tetraseal™ 1123
Flow Tube
Kit #
503213
Kit #
503214
Kit #
503215 1012
1152 1010 1021 502459 507573 502117 1011 1031
Float Ball 1576 1005 1029 1005 1154 1154 1005 1029
Body
Assembly
1891 1897 502053 505271 504407 504823 504407 504434 504824
Knob 1007 1008
Holder 506176 NA
* 8MFA Models DO NOT have serviceable parts.
International parts specifications and specific ratings are available upon request.