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FDA 510(k)

CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000

K-Number: K992575 · 1999-10-07

ApplicantInfimed, Inc.
Decision Date1999-10-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Infimed, Inc.. It received FDA 510(k) clearance on 1999-10-07 under 510(k) number K992575. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000?

CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 is a medical device that received FDA 510(k) clearance on 1999-10-07. The listed applicant is Infimed, Inc.. The 510(k) number is K992575.

When did CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 receive FDA 510(k) clearance?

CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 received FDA 510(k) clearance on 1999-10-07, under 510(k) number K992575.

Who is the listed applicant for CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000?

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

What is the FDA product code for CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000?

The FDA product code for CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 is LLZ.

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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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