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FDA 510(k)

REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)

K-Number: K010791 · 2001-06-08

ApplicantAdsis , Ltd.
Decision Date2001-06-08
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) is the device name listed in this FDA 510(k) record. The listed applicant is Adsis , Ltd.. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K010791. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)?

REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Adsis , Ltd.. The 510(k) number is K010791.

When did REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) receive FDA 510(k) clearance?

REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) received FDA 510(k) clearance on 2001-06-08, under 510(k) number K010791.

Who is the listed applicant for REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)?

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

What is the FDA product code for REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)?

The FDA product code for REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) is DXH. This falls under the Hematology category.

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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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