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FDA 510(k)

COSMOS SYSTEM

K-Number: K013046 · 2002-08-21

ApplicantSpacelabs Medical, Inc.
Decision Date2002-08-21
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COSMOS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Medical, Inc.. It received FDA 510(k) clearance on 2002-08-21 under 510(k) number K013046. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMOS SYSTEM?

COSMOS SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-21. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K013046.

When did COSMOS SYSTEM receive FDA 510(k) clearance?

COSMOS SYSTEM received FDA 510(k) clearance on 2002-08-21, under 510(k) number K013046.

Who is the listed applicant for COSMOS SYSTEM?

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

What is the FDA product code for COSMOS SYSTEM?

The FDA product code for COSMOS SYSTEM is DSI.

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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.

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