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FDA 510(k)

INFUSION PUMP & IV SETS #4000

K-Number: K832755 · 1983-11-03

ApplicantOmni-Glow, Inc.
Decision Date1983-11-03
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION PUMP & IV SETS #4000 is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Glow, Inc.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K832755. 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 INFUSION PUMP & IV SETS #4000?

INFUSION PUMP & IV SETS #4000 is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Omni-Glow, Inc.. The 510(k) number is K832755.

When did INFUSION PUMP & IV SETS #4000 receive FDA 510(k) clearance?

INFUSION PUMP & IV SETS #4000 received FDA 510(k) clearance on 1983-11-03, under 510(k) number K832755.

Who is the listed applicant for INFUSION PUMP & IV SETS #4000?

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

What is the FDA product code for INFUSION PUMP & IV SETS #4000?

The FDA product code for INFUSION PUMP & IV SETS #4000 is FRN.

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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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