The following data is part of a premarket notification filed by Lauer Ltd., Hong Kong with the FDA for Aquaboss Ecoro Dia 50.
Device ID | K032004 |
510k Number | K032004 |
Device Name: | AQUABOSS ECORO DIA 50 |
Classification | Subsystem, Water Purification |
Applicant | LAUER LTD., HONG KONG SPEICHERMATT 9 Wittlingen, DE 79599 |
Contact | Stephan Krietemeyer |
Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-06-30 |
Decision Date | 2003-10-02 |
Summary: | summary |