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FDA 510(k)

RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE

K-Number: K831259 · 1983-05-09

ApplicantCardiac Pacemakers, Inc.
Decision Date1983-05-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE 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 1983-05-09 under 510(k) number K831259. 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 RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE?

RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K831259.

When did RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE receive FDA 510(k) clearance?

RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831259.

Who is the listed applicant for RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE?

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 RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE?

The FDA product code for RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE 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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