FDA 510(k)

INTERMEDICS THIN LITH IV SERIES UNIPOLAR

K-Number: K801450 · 1980-08-14

Decision Date1980-08-14

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTERMEDICS THIN LITH IV SERIES UNIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1980-08-14 under 510(k) number K801450. 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 INTERMEDICS THIN LITH IV SERIES UNIPOLAR?

INTERMEDICS THIN LITH IV SERIES UNIPOLAR is a medical device that received FDA 510(k) clearance on 1980-08-14. The listed applicant is Intermedics, Inc.. The 510(k) number is K801450.

When did INTERMEDICS THIN LITH IV SERIES UNIPOLAR receive FDA 510(k) clearance?

INTERMEDICS THIN LITH IV SERIES UNIPOLAR received FDA 510(k) clearance on 1980-08-14, under 510(k) number K801450.

Who is the listed applicant for INTERMEDICS THIN LITH IV SERIES UNIPOLAR?

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 INTERMEDICS THIN LITH IV SERIES UNIPOLAR?

The FDA product code for INTERMEDICS THIN LITH IV SERIES UNIPOLAR is DXY. This falls under the Clinical Chemistry category.

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Other records listing Intermedics, Inc. as applicant

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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.