FDA 510(k)

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)

K-Number: K040300 · 2004-03-03

Decision Date2004-03-03

Product CodeERL

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2004-03-03 under 510(k) number K040300. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) is a medical device that received FDA 510(k) clearance on 2004-03-03. The listed applicant is Stryker Instruments. The 510(k) number is K040300.

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

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) received FDA 510(k) clearance on 2004-03-03, under 510(k) number K040300.

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

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)?

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

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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.