FDA 510(k)

MEGA PURE CART

K-Number: K031832 · 2004-10-20

Decision Date2004-10-20

Product CodeFIP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MEGA PURE CART is the device name listed in this FDA 510(k) record. The listed applicant is Mega Services. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K031832. 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 MEGA PURE CART?

MEGA PURE CART is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Mega Services. The 510(k) number is K031832.

When did MEGA PURE CART receive FDA 510(k) clearance?

MEGA PURE CART received FDA 510(k) clearance on 2004-10-20, under 510(k) number K031832.

Who is the listed applicant for MEGA PURE CART?

The FDA 510(k) record lists Mega Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEGA PURE CART?

The FDA product code for MEGA PURE CART is FIP.

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, LLC K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC K252181AquaAFresenius Medical Care North America K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC K223479AQUAbase nXB.Braun Medical, Inc.

Official Source

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