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FDA 510(k)

CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0

K-Number: K052537 · 2005-11-16

ApplicantAmerican Medical Sales, Inc.
Decision Date2005-11-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Sales, Inc.. It received FDA 510(k) clearance on 2005-11-16 under 510(k) number K052537. 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 CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0?

CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 is a medical device that received FDA 510(k) clearance on 2005-11-16. The listed applicant is American Medical Sales, Inc.. The 510(k) number is K052537.

When did CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 receive FDA 510(k) clearance?

CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 received FDA 510(k) clearance on 2005-11-16, under 510(k) number K052537.

Who is the listed applicant for CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0?

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

What is the FDA product code for CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0?

The FDA product code for CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 is LLZ.

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Other records listing American Medical Sales, Inc. as applicant

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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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