FDA 510(k)

CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC

K-Number: K823863 · 1983-03-10

Decision Date1983-03-10

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1983-03-10 under 510(k) number K823863. 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 CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC?

CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC is a medical device that received FDA 510(k) clearance on 1983-03-10. The listed applicant is Intermedics, Inc.. The 510(k) number is K823863.

When did CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC receive FDA 510(k) clearance?

CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC received FDA 510(k) clearance on 1983-03-10, under 510(k) number K823863.

Who is the listed applicant for CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC?

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

What is the FDA product code for CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC?

The FDA product code for CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC is DXY. This falls under the Clinical Chemistry category.

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Other records listing Intermedics, Inc. as applicant

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Related Devices (Code: DXY)

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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.