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FDA 510(k)

COMMAND P5(UNIPOLAR PULSE GENERATOR)

K-Number: K811401 · 1981-07-27

ApplicantCardiac Pacemakers, Inc.
Decision Date1981-07-27
Product Code
DecisionSubstantially Equivalent

Device Summary

COMMAND P5(UNIPOLAR PULSE GENERATOR) 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 1981-07-27 under 510(k) number K811401. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMMAND P5(UNIPOLAR PULSE GENERATOR)?

COMMAND P5(UNIPOLAR PULSE GENERATOR) is a medical device that received FDA 510(k) clearance on 1981-07-27. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K811401.

When did COMMAND P5(UNIPOLAR PULSE GENERATOR) receive FDA 510(k) clearance?

COMMAND P5(UNIPOLAR PULSE GENERATOR) received FDA 510(k) clearance on 1981-07-27, under 510(k) number K811401.

Who is the listed applicant for COMMAND P5(UNIPOLAR PULSE GENERATOR)?

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

Related Clinical Trials

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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Other records listing Cardiac Pacemakers, Inc. as applicant

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.

K093969ACUITY BREAK-AWAY GUIDE CATHETERK080154ACUITY UNIVERSAL CUTTERK934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERK920601ASTRA T2, ASTRA T4, ASTRA T6K912379PDT CARRYALL TRANSMITTER, VARIOUS MODELSK905674LEAD STYLET

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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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