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FDA 510(k)

D2RF DIGITAL DYNAMIC REMOTE SYSTEM

K-Number: K102529 · 2010-10-07

ApplicantStephanix Radiological Systems
Decision Date2010-10-07
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

D2RF DIGITAL DYNAMIC REMOTE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stephanix Radiological Systems. It received FDA 510(k) clearance on 2010-10-07 under 510(k) number K102529. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D2RF DIGITAL DYNAMIC REMOTE SYSTEM?

D2RF DIGITAL DYNAMIC REMOTE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is Stephanix Radiological Systems. The 510(k) number is K102529.

When did D2RF DIGITAL DYNAMIC REMOTE SYSTEM receive FDA 510(k) clearance?

D2RF DIGITAL DYNAMIC REMOTE SYSTEM received FDA 510(k) clearance on 2010-10-07, under 510(k) number K102529.

Who is the listed applicant for D2RF DIGITAL DYNAMIC REMOTE SYSTEM?

The FDA 510(k) record lists Stephanix Radiological Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D2RF DIGITAL DYNAMIC REMOTE SYSTEM?

The FDA product code for D2RF DIGITAL DYNAMIC REMOTE SYSTEM is OWB.

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Related Devices (Code: OWB)

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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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