Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MD400 A/B/C/D/E/F/G

K-Number: K944385 · 1995-04-28

ApplicantInternational Purification Systems, Inc.
Decision Date1995-04-28
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MD400 A/B/C/D/E/F/G is the device name listed in this FDA 510(k) record. The listed applicant is International Purification Systems, Inc.. It received FDA 510(k) clearance on 1995-04-28 under 510(k) number K944385. 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 MD400 A/B/C/D/E/F/G?

MD400 A/B/C/D/E/F/G is a medical device that received FDA 510(k) clearance on 1995-04-28. The listed applicant is International Purification Systems, Inc.. The 510(k) number is K944385.

When did MD400 A/B/C/D/E/F/G receive FDA 510(k) clearance?

MD400 A/B/C/D/E/F/G received FDA 510(k) clearance on 1995-04-28, under 510(k) number K944385.

Who is the listed applicant for MD400 A/B/C/D/E/F/G?

The FDA 510(k) record lists International Purification Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MD400 A/B/C/D/E/F/G?

The FDA product code for MD400 A/B/C/D/E/F/G 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, 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.

↑