FDA 510(k)

QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR

K-Number: K850252 · 1985-04-04

Decision Date1985-04-04

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR 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 K850252. 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 QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR?

QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR 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 K850252.

When did QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR receive FDA 510(k) clearance?

QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR received FDA 510(k) clearance on 1985-04-04, under 510(k) number K850252.

Who is the listed applicant for QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR?

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 QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR?

The FDA product code for QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.