FDA 510(k)

IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC

K-Number: K800573 · 1980-03-25

Decision Date1980-03-25

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800573. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC?

IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Telectronics, Inc.. The 510(k) number is K800573.

When did IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC receive FDA 510(k) clearance?

IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800573.

Who is the listed applicant for IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC?

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

What is the FDA product code for IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC?

The FDA product code for IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC is DXY. This falls under the Clinical Chemistry category.

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Other records listing Telectronics, Inc. as applicant

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Related Devices (Code: DXY)

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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.