FDA 510(k)

PRIMA 236-02 NONPROGRAMMABLE CARDIAC

K-Number: K841404 · 1984-05-30

Decision Date1984-05-30

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRIMA 236-02 NONPROGRAMMABLE 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 1984-05-30 under 510(k) number K841404. 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 PRIMA 236-02 NONPROGRAMMABLE CARDIAC?

PRIMA 236-02 NONPROGRAMMABLE CARDIAC is a medical device that received FDA 510(k) clearance on 1984-05-30. The listed applicant is Intermedics, Inc.. The 510(k) number is K841404.

When did PRIMA 236-02 NONPROGRAMMABLE CARDIAC receive FDA 510(k) clearance?

PRIMA 236-02 NONPROGRAMMABLE CARDIAC received FDA 510(k) clearance on 1984-05-30, under 510(k) number K841404.

Who is the listed applicant for PRIMA 236-02 NONPROGRAMMABLE 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 PRIMA 236-02 NONPROGRAMMABLE CARDIAC?

The FDA product code for PRIMA 236-02 NONPROGRAMMABLE CARDIAC is DXY. This falls under the Clinical Chemistry category.

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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.