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FDA 510(k)

HEMO-RO

K-Number: K771763 · 1977-10-04

ApplicantMillipore Corp.
Decision Date1977-10-04
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMO-RO is the device name listed in this FDA 510(k) record. The listed applicant is Millipore Corp.. It received FDA 510(k) clearance on 1977-10-04 under 510(k) number K771763. 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 HEMO-RO?

HEMO-RO is a medical device that received FDA 510(k) clearance on 1977-10-04. The listed applicant is Millipore Corp.. The 510(k) number is K771763.

When did HEMO-RO receive FDA 510(k) clearance?

HEMO-RO received FDA 510(k) clearance on 1977-10-04, under 510(k) number K771763.

Who is the listed applicant for HEMO-RO?

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

What is the FDA product code for HEMO-RO?

The FDA product code for HEMO-RO 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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