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FDA 510(k)

OPEN LOOP AMBULATORY INSULIN INFUSION

K-Number: K820073 · 1982-01-25

ApplicantCardiac Pacemakers, Inc.
Decision Date1982-01-25
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPEN LOOP AMBULATORY INSULIN INFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1982-01-25 under 510(k) number K820073. 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 AMBULATORY INSULIN INFUSION?

OPEN LOOP AMBULATORY INSULIN INFUSION is a medical device that received FDA 510(k) clearance on 1982-01-25. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K820073.

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

OPEN LOOP AMBULATORY INSULIN INFUSION received FDA 510(k) clearance on 1982-01-25, under 510(k) number K820073.

Who is the listed applicant for OPEN LOOP AMBULATORY INSULIN INFUSION?

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

What is the FDA product code for OPEN LOOP AMBULATORY INSULIN INFUSION?

The FDA product code for OPEN LOOP AMBULATORY INSULIN INFUSION 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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