FDA 510(k)

IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW

K-Number: K853206 · 1985-09-12

Decision Date1985-09-12

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1985-09-12 under 510(k) number K853206. 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 IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW?

IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW is a medical device that received FDA 510(k) clearance on 1985-09-12. The listed applicant is Telectronics, Inc.. The 510(k) number is K853206.

When did IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW receive FDA 510(k) clearance?

IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW received FDA 510(k) clearance on 1985-09-12, under 510(k) number K853206.

Who is the listed applicant for IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW?

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 IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW?

The FDA product code for IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW 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.