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FDA 510(k)

THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM

K-Number: K882594 · 1988-09-20

ApplicantOmni-Flow, Inc.
Decision Date1988-09-20
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Flow, Inc.. It received FDA 510(k) clearance on 1988-09-20 under 510(k) number K882594. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM?

THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1988-09-20. The listed applicant is Omni-Flow, Inc.. The 510(k) number is K882594.

When did THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM received FDA 510(k) clearance on 1988-09-20, under 510(k) number K882594.

Who is the listed applicant for THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM?

The FDA 510(k) record lists Omni-Flow, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM?

The FDA product code for THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM is FRN.

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Related Devices (Code: FRN)

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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.

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