The following data is part of a premarket notification filed by Ibp Instruments Gmbh with the FDA for Conductivity Standard Solution-metercare.
Device ID | K032075 |
510k Number | K032075 |
Device Name: | CONDUCTIVITY STANDARD SOLUTION-METERCARE |
Classification | Solution-test Standard-conductivity, Dialysis |
Applicant | IBP INSTRUMENTS GMBH SUTELSTRASSE 7A Hannover, DE D30659 |
Contact | Werner Pfingstmann |
Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | FKH |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-07-07 |
Decision Date | 2003-09-17 |
Summary: | summary |