FDA 510(k)

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

K-Number: K032303 · 2004-01-16

Decision Date2004-01-16

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2004-01-16 under 510(k) number K032303. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-16. The listed applicant is Stryker Instruments. The 510(k) number is K032303.

When did STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM receive FDA 510(k) clearance?

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM received FDA 510(k) clearance on 2004-01-16, under 510(k) number K032303.

Who is the listed applicant for STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

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

What is the FDA product code for STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

The FDA product code for STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM is HBE.

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