FDA 510(k)

PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT

K-Number: K782146 · 1978-12-27

Decision Date1978-12-27

Product CodeDXY

Advisory CommitteeCV

DecisionUnknown

Device Summary

PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Arco Medical Products Co.. It received FDA 510(k) clearance on 1978-12-27 under 510(k) number K782146. 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: Unknown.

Frequently Asked Questions

What is the PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT?

PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT is a medical device that received FDA 510(k) clearance on 1978-12-27. The listed applicant is Arco Medical Products Co.. The 510(k) number is K782146.

When did PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT receive FDA 510(k) clearance?

PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT received FDA 510(k) clearance on 1978-12-27, under 510(k) number K782146.

Who is the listed applicant for PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT?

The FDA 510(k) record lists Arco Medical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT?

The FDA product code for PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT is DXY. This falls under the Clinical Chemistry category.

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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.