FDA 510(k)

INTERMEDICS CYBERLITH I BIOPOLAR CARDI

K-Number: K810383 · 1981-04-01

Decision Date1981-04-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTERMEDICS CYBERLITH I BIOPOLAR CARDI is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1981-04-01 under 510(k) number K810383. 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 INTERMEDICS CYBERLITH I BIOPOLAR CARDI?

INTERMEDICS CYBERLITH I BIOPOLAR CARDI is a medical device that received FDA 510(k) clearance on 1981-04-01. The listed applicant is Intermedics, Inc.. The 510(k) number is K810383.

When did INTERMEDICS CYBERLITH I BIOPOLAR CARDI receive FDA 510(k) clearance?

INTERMEDICS CYBERLITH I BIOPOLAR CARDI received FDA 510(k) clearance on 1981-04-01, under 510(k) number K810383.

Who is the listed applicant for INTERMEDICS CYBERLITH I BIOPOLAR CARDI?

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 INTERMEDICS CYBERLITH I BIOPOLAR CARDI?

The FDA product code for INTERMEDICS CYBERLITH I BIOPOLAR CARDI 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.