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FDA 510(k)

BETATRON IV SYSTEM

K-Number: K872774 · 1988-01-05

ApplicantCardiac Pacemakers, Inc.
Decision Date1988-01-05
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BETATRON IV SYSTEM 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 1988-01-05 under 510(k) number K872774. 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 BETATRON IV SYSTEM?

BETATRON IV SYSTEM is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K872774.

When did BETATRON IV SYSTEM receive FDA 510(k) clearance?

BETATRON IV SYSTEM received FDA 510(k) clearance on 1988-01-05, under 510(k) number K872774.

Who is the listed applicant for BETATRON IV SYSTEM?

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 BETATRON IV SYSTEM?

The FDA product code for BETATRON IV SYSTEM is FRN.

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Other records listing Cardiac Pacemakers, Inc. as applicant

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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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