FDA 510(k)

IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II

K-Number: K851081 · 1985-04-04

Decision Date1985-04-04

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1985-04-04 under 510(k) number K851081. 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 IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II?

IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II is a medical device that received FDA 510(k) clearance on 1985-04-04. The listed applicant is Telectronics, Inc.. The 510(k) number is K851081.

When did IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II receive FDA 510(k) clearance?

IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II received FDA 510(k) clearance on 1985-04-04, under 510(k) number K851081.

Who is the listed applicant for IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II?

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

What is the FDA product code for IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II?

The FDA product code for IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II is DXY. This falls under the Clinical Chemistry category.

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Other records listing Telectronics, Inc. as applicant

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Related Devices (Code: DXY)

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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.