FDA 510(k)

CYBERLITH I PULSE GENERATOR MODEL 253-04

K-Number: K810385 · 1981-04-01

Decision Date1981-04-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CYBERLITH I PULSE GENERATOR MODEL 253-04 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1981-04-01 under 510(k) number K810385. 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 CYBERLITH I PULSE GENERATOR MODEL 253-04?

CYBERLITH I PULSE GENERATOR MODEL 253-04 is a medical device that received FDA 510(k) clearance on 1981-04-01. The listed applicant is Intermedics, Inc.. The 510(k) number is K810385.

When did CYBERLITH I PULSE GENERATOR MODEL 253-04 receive FDA 510(k) clearance?

CYBERLITH I PULSE GENERATOR MODEL 253-04 received FDA 510(k) clearance on 1981-04-01, under 510(k) number K810385.

Who is the listed applicant for CYBERLITH I PULSE GENERATOR MODEL 253-04?

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

What is the FDA product code for CYBERLITH I PULSE GENERATOR MODEL 253-04?

The FDA product code for CYBERLITH I PULSE GENERATOR MODEL 253-04 is DXY. This falls under the Clinical Chemistry category.

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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.