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FDA 510(k)

MONITOR, PACEMAKER

K-Number: K770865 · 1977-06-14

ApplicantAdcor Electronics, Inc.
Decision Date1977-06-14
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, PACEMAKER is the device name listed in this FDA 510(k) record. The listed applicant is Adcor Electronics, Inc.. It received FDA 510(k) clearance on 1977-06-14 under 510(k) number K770865. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, PACEMAKER?

MONITOR, PACEMAKER is a medical device that received FDA 510(k) clearance on 1977-06-14. The listed applicant is Adcor Electronics, Inc.. The 510(k) number is K770865.

When did MONITOR, PACEMAKER receive FDA 510(k) clearance?

MONITOR, PACEMAKER received FDA 510(k) clearance on 1977-06-14, under 510(k) number K770865.

Who is the listed applicant for MONITOR, PACEMAKER?

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

What is the FDA product code for MONITOR, PACEMAKER?

The FDA product code for MONITOR, PACEMAKER is DTC.

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Related Devices (Code: DTC)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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