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FDA 510(k)

OPEN LOOP INFUSION PUMP

K-Number: K820219 · 1982-02-10

ApplicantIatric Devices
Decision Date1982-02-10
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPEN LOOP INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Iatric Devices. It received FDA 510(k) clearance on 1982-02-10 under 510(k) number K820219. 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 OPEN LOOP INFUSION PUMP?

OPEN LOOP INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1982-02-10. The listed applicant is Iatric Devices. The 510(k) number is K820219.

When did OPEN LOOP INFUSION PUMP receive FDA 510(k) clearance?

OPEN LOOP INFUSION PUMP received FDA 510(k) clearance on 1982-02-10, under 510(k) number K820219.

Who is the listed applicant for OPEN LOOP INFUSION PUMP?

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

What is the FDA product code for OPEN LOOP INFUSION PUMP?

The FDA product code for OPEN LOOP INFUSION PUMP is FRN.

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Related Devices (Code: FRN)

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.

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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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