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FDA 510(k)

REMOTE PRESENCE SYSTEM, MODEL RP-VITA

K-Number: K123229 · 2012-11-20

Decision Date2012-11-20
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REMOTE PRESENCE SYSTEM, MODEL RP-VITA is the device name listed in this FDA 510(k) record. The listed applicant is Intouch Health, Inc.. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K123229. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE PRESENCE SYSTEM, MODEL RP-VITA?

REMOTE PRESENCE SYSTEM, MODEL RP-VITA is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Intouch Health, Inc.. The 510(k) number is K123229.

When did REMOTE PRESENCE SYSTEM, MODEL RP-VITA receive FDA 510(k) clearance?

REMOTE PRESENCE SYSTEM, MODEL RP-VITA received FDA 510(k) clearance on 2012-11-20, under 510(k) number K123229.

Who is the listed applicant for REMOTE PRESENCE SYSTEM, MODEL RP-VITA?

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

What is the FDA product code for REMOTE PRESENCE SYSTEM, MODEL RP-VITA?

The FDA product code for REMOTE PRESENCE SYSTEM, MODEL RP-VITA is DRG.

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.

Other records listing Intouch Health, 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.

Related Devices (Code: DRG)

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.

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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