The following data is part of a premarket notification filed by Lauer Membran Wassertechnik Gmbh with the FDA for Aquaboss Ecoro Dia I (ht); Aquaboss Ecoro Dia Ii (ht).
Device ID | K124059 |
510k Number | K124059 |
Device Name: | AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) |
Classification | Subsystem, Water Purification |
Applicant | LAUER MEMBRAN WASSERTECHNIK GMBH 9 SPEICHERMATT Wittlingen, DE De 79599 |
Contact | Stephan Krietemeyer |
Correspondent | Stephan Krietemeyer LAUER MEMBRAN WASSERTECHNIK GMBH 9 SPEICHERMATT Wittlingen, DE De 79599 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-31 |
Decision Date | 2013-03-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04046964859502 | K124059 | 000 |
04046964859755 | K124059 | 000 |
04046964859779 | K124059 | 000 |
04046964859793 | K124059 | 000 |
04046964859816 | K124059 | 000 |
04046964859830 | K124059 | 000 |
04046964859854 | K124059 | 000 |
04046964841866 | K124059 | 000 |
04046964842931 | K124059 | 000 |
04046964859731 | K124059 | 000 |
04046964859724 | K124059 | 000 |
04046964859663 | K124059 | 000 |
04046964859540 | K124059 | 000 |
04046964859557 | K124059 | 000 |
04046964859564 | K124059 | 000 |
04046964859588 | K124059 | 000 |
04046964859625 | K124059 | 000 |
04046964859632 | K124059 | 000 |
04046964859649 | K124059 | 000 |
04046964859656 | K124059 | 000 |
04046964843037 | K124059 | 000 |
04046964859519 | K124059 | 000 |
04046964859526 | K124059 | 000 |
04046964859762 | K124059 | 000 |
04046964859786 | K124059 | 000 |
04046964859809 | K124059 | 000 |
04046964859823 | K124059 | 000 |
04046964859847 | K124059 | 000 |
04046964859861 | K124059 | 000 |
04046964859878 | K124059 | 000 |
04046964859885 | K124059 | 000 |
04046964859748 | K124059 | 000 |
04046964859717 | K124059 | 000 |
04046964859700 | K124059 | 000 |
04046964859533 | K124059 | 000 |
04046964859571 | K124059 | 000 |
04046964859595 | K124059 | 000 |
04046964859601 | K124059 | 000 |
04046964859618 | K124059 | 000 |
04046964859670 | K124059 | 000 |
04046964859687 | K124059 | 000 |
04046964859694 | K124059 | 000 |
04046964859892 | K124059 | 000 |