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FDA 510(k)

CENTRAL STATION, VERSION 3.3H

K-Number: K040032 · 2004-02-27

ApplicantHommed, LLC
Decision Date2004-02-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRAL STATION, VERSION 3.3H is the device name listed in this FDA 510(k) record. The listed applicant is Hommed, LLC. It received FDA 510(k) clearance on 2004-02-27 under 510(k) number K040032. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRAL STATION, VERSION 3.3H?

CENTRAL STATION, VERSION 3.3H is a medical device that received FDA 510(k) clearance on 2004-02-27. The listed applicant is Hommed, LLC. The 510(k) number is K040032.

When did CENTRAL STATION, VERSION 3.3H receive FDA 510(k) clearance?

CENTRAL STATION, VERSION 3.3H received FDA 510(k) clearance on 2004-02-27, under 510(k) number K040032.

Who is the listed applicant for CENTRAL STATION, VERSION 3.3H?

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

What is the FDA product code for CENTRAL STATION, VERSION 3.3H?

The FDA product code for CENTRAL STATION, VERSION 3.3H is DXN.

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Other records listing Hommed, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040799HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONSK040651HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEMK020184HOMMED CENTRAL STATIONK014025HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READERK003180HOMMED OBSERVER, MODEL IK004044HOMMED SENTRY III PATIENT MONITOR SYSTEM

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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