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FDA 510(k)

EHC500 DESKTOP PATIENT STATION, MODEL EHC500

K-Number: K002388 · 2000-08-25

ApplicantCybercare, Inc.
Decision Date2000-08-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EHC500 DESKTOP PATIENT STATION, MODEL EHC500 is the device name listed in this FDA 510(k) record. The listed applicant is Cybercare, Inc.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K002388. 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 EHC500 DESKTOP PATIENT STATION, MODEL EHC500?

EHC500 DESKTOP PATIENT STATION, MODEL EHC500 is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Cybercare, Inc.. The 510(k) number is K002388.

When did EHC500 DESKTOP PATIENT STATION, MODEL EHC500 receive FDA 510(k) clearance?

EHC500 DESKTOP PATIENT STATION, MODEL EHC500 received FDA 510(k) clearance on 2000-08-25, under 510(k) number K002388.

Who is the listed applicant for EHC500 DESKTOP PATIENT STATION, MODEL EHC500?

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

What is the FDA product code for EHC500 DESKTOP PATIENT STATION, MODEL EHC500?

The FDA product code for EHC500 DESKTOP PATIENT STATION, MODEL EHC500 is DXN.

Related Clinical Trials

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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Other records listing Cybercare, Inc. 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.

K000237EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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