FDA 510(k)

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066

K-Number: K882427 · 1988-09-23

Decision Date1988-09-23

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1988-09-23 under 510(k) number K882427. 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 CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066?

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 is a medical device that received FDA 510(k) clearance on 1988-09-23. The listed applicant is Ela Medical, Inc.. The 510(k) number is K882427.

When did CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 receive FDA 510(k) clearance?

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 received FDA 510(k) clearance on 1988-09-23, under 510(k) number K882427.

Who is the listed applicant for CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066?

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

What is the FDA product code for CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066?

The FDA product code for CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 is DXY. This falls under the Clinical Chemistry category.

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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.