FDA 510(k)

OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR

K-Number: K894185 · 1989-08-17

ApplicantTelectronics Pacing Systems, Inc.

Decision Date1989-08-17

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics Pacing Systems, Inc.. It received FDA 510(k) clearance on 1989-08-17 under 510(k) number K894185. 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 OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR?

OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR is a medical device that received FDA 510(k) clearance on 1989-08-17. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K894185.

When did OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR receive FDA 510(k) clearance?

OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR received FDA 510(k) clearance on 1989-08-17, under 510(k) number K894185.

Who is the listed applicant for OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR?

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

What is the FDA product code for OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR?

The FDA product code for OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR 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.