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FDA 510(k)

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)

K-Number: K124059 · 2013-03-25

ApplicantLauer Membran Wassertechnik GmbH
Decision Date2013-03-25
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) is the device name listed in this FDA 510(k) record. The listed applicant is Lauer Membran Wassertechnik GmbH. It received FDA 510(k) clearance on 2013-03-25 under 510(k) number K124059. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)?

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) is a medical device that received FDA 510(k) clearance on 2013-03-25. The listed applicant is Lauer Membran Wassertechnik GmbH. The 510(k) number is K124059.

When did AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) receive FDA 510(k) clearance?

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) received FDA 510(k) clearance on 2013-03-25, under 510(k) number K124059.

Who is the listed applicant for AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)?

The FDA 510(k) record lists Lauer Membran Wassertechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)?

The FDA product code for AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) is FIP.

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Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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