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FDA 510(k)

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123

K-Number: K852060 · 1985-06-07

ApplicantCardiac Pacemakers, Inc.
Decision Date1985-06-07
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 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 1985-06-07 under 510(k) number K852060. 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 SETS MODELS 9120,9121,9125, 9122 & 9123?

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 is a medical device that received FDA 510(k) clearance on 1985-06-07. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K852060.

When did INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 receive FDA 510(k) clearance?

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 received FDA 510(k) clearance on 1985-06-07, under 510(k) number K852060.

Who is the listed applicant for INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123?

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 INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123?

The FDA product code for INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 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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