FDA 510(k)

INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG

K-Number: K920530 · 1992-03-17

Decision Date1992-03-17

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1992-03-17 under 510(k) number K920530. 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 MODEL 366-15 VS 1 HEADER PLUG?

INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG is a medical device that received FDA 510(k) clearance on 1992-03-17. The listed applicant is Intermedics, Inc.. The 510(k) number is K920530.

When did INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG receive FDA 510(k) clearance?

INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG received FDA 510(k) clearance on 1992-03-17, under 510(k) number K920530.

Who is the listed applicant for INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG?

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 MODEL 366-15 VS 1 HEADER PLUG?

The FDA product code for INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG is DXY. This falls under the Clinical Chemistry category.

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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.